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Inspection and Field Testing of Radiation-Emitting Electronic Products

Program 7386.001

CHAPTER 86 MEDICAL AND RADIOLOGICAL DEVICE MONITORING AND QUALITY CONFORMANCE

This compliance program consolidates and supersedes the following compliance programs:

• 7386.001 – Inspection of Manufacturers of Laser Products
• 7386.002 – Field Implementation of the Sunlamp and Sunlamp Products Performance Standard As Amended
• 7386.004 – Field Compliance Testing of Cabinet X-Ray Equipment

FIELD REPORTING REQUIREMENTS

• Submit all Establishment Inspection Reports (EIRs) and field test reports, attachments, exhibits, correspondence between the district and firm, and other documentation to:

Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
ATTN: Electronic Products Branch (HFZ-240)
1350 Piccard Dr .
Rockville MD 20850 .

• Copies of the EIRs and field test reports, attachments, exhibits, correspondence between the district and firm and other documentation should be routed to appropriate Radiological Health staff, as identified in Part VI of this program, to the accomplishing district and to the district where the firm is located (if located in a different district from the accomplishing district).

• All FACTS and PODS data should be entered by the accomplishing district where the operation was performed.

This document represents the agency’s current thinking on the enforcement of the Federal Food Drug and Cosmetic Act Electronic Product Radiation Control provisions and related regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

PART I - BACKGROUND

This compliance program provides guidance to FDA field and center staff for the inspection, field test and administrative/enforcement activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food Drug and Cosmetic Act (FFDCA, the Act) and regulations contained in Title 21 of the Code of Federal Regulations, Parts 1000 – 1050 (21 CFR 1000 – 1050). The intent of these requirements is to protect the public from unnecessary exposure to electronic products radiation. Manufacturers are responsible for producing products that do not emit hazardous or unnecessary radiation and that comply with all applicable radiation safety performance standards. All electronic product manufacturers must comply with applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the specific standard found in 21 CFR 1020 – 1050. Manufacturers are required to self-certify their own products to be compliant with an applicable standard, based on a quality control testing program as described in 21 CFR 1010.2. The purpose of EPRC inspections and field tests are to verify that products comply with performance standards, and that the manufacturer’s quality control testing program ensures such product compliance and radiation safety.

This program applies to certain electronic products subject to radiation safety performance standards described in 21 CFR 1010 – 1040, including:

• 21 CFR 1020.10 Television Receivers
• 21 CFR 1020.40 Cabinet X-Ray Systems
• 21 CFR 1030.10 Microwave Ovens
• 21 CFR 1040.10 Lasers and Laser Systems
• 21 CFR 1040.11 Specific Purpose Laser Products
• 21 CFR 1040.20 Sunlamps and Sunlamp Products

Diagnostic x-ray inspection and testing is conducted under Compliance Program 7386.001. Products and manufacturers subject to standards contained in 21 CFR 1020 – 1050, but are not listed above, will be subject to inspection or test on a for-cause basis only at the direction of CDRH.

The body of this program contains basic instructions for inspection, field test and administrative/enforcement activities applicable to all electronic products. Inspection and field test checklists, and additional considerations and instructions for specific products, such as laser, sunlamp, cabinet x-ray, television and microwave oven products, are covered in ATTACHMENTS B - F.

Medical devices that emit electronic product radiation are subject to EPRC requirements as well as Medical Device provisions of the Act and related regulations. Medical device inspection and enforcement activities described in Compliance Program 7382.845, Inspection of Medical Device Manufacturers, may be conducted jointly with this program at CDRH and district discretion. Examples of radiation-emitting medical devices include medical laser and sunlamp products, which could be covered by a joint EPRC/medical device inspection.

PART II – PROGRAM/IMPLEMENTATION

A. OBJECTIVES

This is a continuing, non-statistical compliance program intended:

1. To evaluate an electronic product manufacturer’s quality control testing program for its ability to ensure such product compliance and radiation safety.
2. To identify certified electronic products which fail to comply with the requirements of applicable performance standards
3. To obtain correction of deficient quality control testing programs and noncompliant products identified by initiating appropriate administrative/regulatory action.
4. To provide guidance to manufacturers regarding compliance with the laws and regulations administered by FDA.

B. PROGRAM MANAGEMENT INSTRUCTIONS

1. Planning Instructions

1. The role of the individual investigator and field radiological health specialists is a critical factor for the effective implementation of this program. Field specialists such as Electro-Optics Specialists (EOS) and Regional Radiological Health Representatives have been specifically trained in general EPRC requirements and may have specialized training in one or more performance standards.
    
   Only individuals trained in EPRC requirements should perform these inspections and field tests. Contact CDRH/OCER Electronic Products Branch (HFZ-240) and DFI (HFC-130) should the need for expertise, not otherwise available in the District, become apparent. At the discretion of CDRH and the district, radiological health specialists may be used to accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an individual has training in both EPRC and medical device inspections, a single individual may conduct both portions of the inspection.
    
2. Field radiological health specialists, their particular area of expertise, physical location and primary geographical areas of responsibility are listed in Part VI of this program.
    
3. Based on the resources in the current FY workplan, field radiological health specialists will develop assignments for their organization. The assignments will be reviewed by his or her supervisor, entered into FACTS and transmitted to the affected field staff, Districts, HFC-l32 and HFZ-240. Workplans should include district inspections, field tests, and known CDRH assignments. The establishment inventory and guidance from CDRH should be used to determine inspection and field test locations.

2. Pre-announcement of Inspections

Pre-announcement of EPRC inspections conducted under this compliance program is not mandatory, although it is recommended to facilitate the inspection. Pre-announcement ensures the firm is producing electronic products for the US market on the day of inspection, gives the firm time to collect all necessary procedures and records, and ensures appropriate individuals are available during the inspection. Section 537 of the Act permits inspection of any manufacturer for good cause, grounds for which may include introduction of any noncompliant product into US commerce, failure to comply with EPRC reporting requirements, or for purposes of suspected problems with a manufacturer’s quality control testing program and product conformance with performance standards.

Inspections of radiation-emitting medical device manufacturers must be pre-announced if the inspection will cover medical device Quality Systems Regulation compliance. Refer to instructions provided in the Guide to Inspections of Quality Systems, August 1999, and IOM Section 5.2.1.1, Pre-Announcements.

3. Pre-announcement of Field Tests

Schedule an appointment with the user prior to the field test. Tell the user that the purpose of the visit is to conduct a survey of an electronic product to determine compliance with FDA’s Federal radiation safety performance standards.

Request that persons familiar with the operation of the electronic product to be tested be available to assist in the operation of the equipment.

4. Inspections and Field Test Priorities

Inspections and field testing of electronic product manufacturers should be prioritized using the following criteria:

1. Manufacturers and products posing a potential risk to public health or with great public health impact. High-risk products may be identified by additional product-specific guidance provided in Attachments B – F, direction provided from CDRH, level of radiation emissions accessible to the public or volume of products on the US market.
2. Manufacturers or products with known compliance problems discovered through field testing, report review, complaints or other reason.
3. New manufacturers that have not yet been inspected
4. Products incorporating technology new to the US market or a major change in existing product.

5. Resource Instructions

1. Field personnel may require personal radiation monitors, such as thermal luminescent dosimeter badges, when performing tests under this program. Dosimeters must be worn when performing inspections of cabinet x-ray manufacturers, cabinet x-ray field tests, and other products that can emit x radiation. These monitors are available from the Winchester Engineering and Analytical Center (WEAC) Radiation Safety Officer. Part VI of this program contains the current list of contacts for WEAC.
    
2. Field personnel are responsible for contacting OCER and OSEL to arrange to have their radiation measurement equipment re-calibrated annually. Any personnel that do not have the appropriate radiation meters may request that equipment be loaned by another district or by CDRH, if available.
    
   CDRH will be phasing out calibration services currently provided for a number of instruments in the field, and alternate sources of equipment maintenance and calibration services will be identified. CDRH will assist in identifying sources for these services, and will maintain an inventory of equipment that may be available for use by field staff on loan.

PART III INSPECTIONAL

A. OPERATIONS

1. Inspectional Strategy

The purpose of electronic product manufacturer inspections is to evaluate the firm’s quality control testing program to ensure product compliance with applicable performance standards and radiation safety. The inspection should also verify that EPRC requirements for reporting and recordkeeping are met by the firm.

2. Electronic Product Radiation Control Inspection

1. Items to cover
   1. The firm’s product(s) comply with the applicable requirements of the standard to the extent that:
      • The product has the applicable performance features, labels, and instructions for operation, maintenance and service
      • The product emissions are properly characterized. If appropriate, request to make measurements during the inspection using available FDA or manufacturer instruments to confirm emission specifications are below any established limits. Otherwise, witness the measurements performed by the manufacturer to confirm.
      • The brochures, catalogs and other promotional material contain any required warnings or label reproductions
   2. The firm has procedures and documents for control of the manufacturing process appropriate to the product type and production volume including:
      • Stock and inventory control
      • Bills of materials
      • Control drawings and procedures that are authenticated and current
      • Incoming inspection, criteria for acceptance/rejection, and segregation of accepted from rejected parts
      • Disposition of rejected parts
      • Finished goods storage and inventory
   3. The firm has quality control testing procedures and records to cover:
      • In-production tests to verify product compliance during production
      • Final test and inspection of finished products
      • Maintenance and calibration of test equipment
   4. The firm maintains records required by the electronic product radiation control regulations:
      • Distribution to first purchasers or distributors
      • Safety related complaints, inquiries
      • Real or alleged injuries
      • Remedial actions taken for reports of non-compliant products, complaints, injuries
      • Reports submitted to CDRH

   Specific product inspection and field test checklists or forms, if available, are included in ATTACHMENTS B – F. These checklists should be used in conjunction with the above guidance to record inspection and test observations.

2. Records to collect
   1. Organization chart identifying key individuals responsible for product design, manufacturing and quality control
   2. Copies of testing procedures and where possible photographic evidence showing that testing does not ensure product safety or compliance with applicable standards
   3. Samples of violative labels
   4. Copies of manuals, in part or whole, that fail to contain required materials
   5. Copies of brochures and catalogs that fail to contain required warning or label reproductions
   6. Distribution records for any violative products
       
3. Foreign inspections
    
   All foreign inspections should be conducted using this guide, and any special instructions contained in the inspection assignment. The failure of any foreign manufacturer to comply with these requirements may result in detention upon entry.
    
   Foreign inspections are subject to scheduling and time constraints as several manufacturers will be inspected in a single trip. Early planning is critical to conducting foreign inspections. Firms inspected must be notified as early as possible to ensure the firm will be producing for the US on the day of inspection, to give the firm time to collect all necessary procedures and records, prepare translations of needed documents, and make arrangements to have a translator available if needed.
    
   Any investigator with appropriate training may conduct foreign EPRC or joint EPRC/medical device inspections. For example, field specialists such as Electro Optics Specialists (EOS) and Regional Radiological Health Representatives have been trained in general EPRC requirements and may have specialized training in one or more performance standards.
    
4. Medical Device Inspections
   Radiation-emitting medical devices are subject to both electronic product radiation control requirements and medical device requirements including the Quality System, Medical Device Reporting (MDR), Medical device Tracking, Corrections and Removal, and Registration and Listing regulations.
    
   Based on district concurrence, a joint EPRC/medical device inspection covering the firm’s compliance with both sets of requirements may be conducted under this compliance program and Compliance Program 7382.845 for Inspection of Medical Device Manufacturers.
   • The EPRC portion of the inspection should follow the instructions provided specifically in this program to determine the firm’s compliance with electronic product radiation control requirements for reporting and recordkeeping, certification to applicable performance standards, and a quality control testing program that ensures product compliance and radiation safety. Report EPRC time under the appropriate PAC identified in this program.
   • The medical device portion of the inspection should follow instructions provided in the medical device inspection compliance program to assess the firm’s quality system. Manufacturers of devices subject to radiation safety performance standards contained in 21 CFR Parts 1020 – 1050 should include in their device master and history records those procedures and records demonstrating compliance with the applicable standard, self-certification (21 CFR 1010), and reporting (21CFR 1002 – 1005). Report medical device time under the appropriate medical device PAC identified in Compliance Program 7382.845.
      
5. For-Cause Directed inspections
   For-cause inspections are conducted in response to specific information that raises questions, concerns, or problems associated with the electronic product. Information can come from a variety of sources including:
   • Sample analysis results
   • Prior inspectional observations
   • Questionable information in product reports
   • Reports of injuries related to the firm’s products
   • Consumer or trade complaints about the firm.
   For cause inspections are usually initiated at the request of CDRH. For-cause inspections will generally follow instructions provided in this compliance program, with additional questions and issues to cover provided in the assignment.
    
6. Inspectional Observations Review
   Review inspectional observations with the most responsible individual and other technical experts at the firm prior to concluding the inspection. Record EPRC observations on the Form FDA-483. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies. Deficiencies should be noted on Form FDA-483 in order of descending importance (i.e. most serious first). If both EPRC and medical device observations are noted, they should be grouped separately on the form.
    
   The district has discretion to offer annotation of the FDA 483 for an EPRC inspection, if the investigator and firm believe annotation will facilitate the inspection process. An offer to annotate the FDA 483 should be extended for all joint EPRC/medical device inspections. When a FDA 483 is annotated, it should be done in accordance with the IOM Chapter 5 (Section 5.2.3).
    
   The following statement should be included on each FDA 483:

   “This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective actions in response to an observation, you may discuss the objection or action with FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above."

   For all medical device inspections the FDA 483 should contain the following additional statement:

   “The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self audits to identify and correct any and all violations of the quality system requirements.”

3. Electronic Product Radiation Control Field Tests

Field tests are examinations of installed electronic products and may be conducted at trade shows, manufacturing facilities or other sites where products are in use. Field tests assess the individual product’s compliance with applicable performance standard requirements alone. It can not be expected that there will be staff on site with expert knowledge of the product being field tested or that it will be possible to evaluate all aspects of product compliance.

1. Items to cover:
   1. Product emissions are properly characterized. If possible, confirm by direct measurement using FDA or available instrumentation on-site documenting all maintenance and calibration information. At a minimum, document claimed product emissions based on product labeling review.
   2. Product incorporates required performance features
   3. Product displays the labels with required contents
   If the product becomes damaged during a field test, the owner, investigator, and supervisor should complete the appropriate sections of the form FDA 2766 entitled, Claim for Damages to an Electronic Product. Instructions for completion are on the back of the form, which is available from the FDA Forms Catalog (see FDA intranet home page under “forms” section).
    
2. Records to collect:
   1. Purchase information documenting the manufacturer and distributor of the product
   2. Supporting documents or photographic evidence for questionable items, including noncompliant user and service manuals, inadequate protective housing, lack of interlocks, or lack of required labeling
   3. Copy of promotional literature to show product specifications and intended use
   4. Samples of violative labels
   5. Copies of manuals (or manual sections) that fail to contain required materials
       
3. Field test observations review
   Review field test observations with the most responsible individual at the location and with other appropriate staff after completing the field test. Deficiencies should be noted in order of descending importance (i.e. most serious first) on the field test record form. If a field test is conducted as part of an inspection, field test results should be noted on the FDA-483 along with inspectional observations.
    
   Share observations by providing a copy of the FDA- 483 and/or field test checklist or form.
    
   Indicate that FDA will follow up with the manufacturer and take action to correct deficiencies, as appropriate. In the event of a Class A hazard, recommend the product should not be used until corrected. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies in ATTACHMENTS A – F.

4. Investigations:

Investigations are to be made to determine whether a suspected firm is in fact a manufacturer of one or more electronic products. The investigation may be initiated in preparation for a possible inspection, as a result of trade complaints, or from discovery via the Internet or printed materials of promotion of products that may not comply with EPRC requirements.

5. Physical and Documentary Samples:

Physical samples of products are generally not collected under this compliance program. Samples are not required to support a letter issued to the firm or further action to include program disapproval or legal action. However, samples can be useful to support inspectional observations to demonstrate inadequacy of the quality control testing program or product noncompliance. The investigator should consult district management and CDRH to determine whether collecting physical samples would support any subsequent letter or action initiated. Documentary samples may be collected when collecting an actual physical sample is not practical and the evidence is necessary to support inspectional observations.

Collect samples according to procedures defined in the Investigations Operations Manual, Chapter 4, and coordinate any sample collection activity with CDRH and WEAC to ensure proper procedures are followed and chain of custody is observed to maintain sample integrity.

PART IV ANALYTICAL

No laboratory testing will be done under this program. CDRH or WEAC testing may be required on special assignments under Compliance Program for Lab Testing CP 7386.006 or as indicated in Part III.A.5 of this program.

PART V REGULATORY/ADMINISTRATIVE FOLLOW UP

A. REGULATORY PHILOSOPHY AND STRATEGY

CDRH is generally responsible for the final review of inspections and field tests made under this program and for the issuance of letters resulting from inspections and field tests performed by field radiological health staff. Exceptions where the district has direct reference authority are noted below under section C, Regulatory Action. The intent of this program is to follow up on problems that pose a radiation safety hazard or are a flagrant violation of EPRC requirements.

Violations of EPRC requirements may include:

• Failure to comply with an applicable performance standard
• Failure to establish and conduct an adequate quality control testing program
• Failure to submit required reports, including initial, model change, annual or accidental radiation occurrence reports

Appropriate regulatory or administrative actions include issuance of a notification of defect or non-compliance letter (warning or untitled letter), requiring repurchase, repair or replacement of product under an approved corrective action plan, or imposition of civil penalties and/or injunction. Appropriate follow-up actions should be determined by CDRH or in consultation with CDRH to ensure consistency in how EPRC requirements are enforced.

CDRH has classified several potential items of non-compliance that might be observed during an inspection or field test and classified those items in terms of health hazard and regulatory action. Tables are provided in Attachments A – F to provide guidance for use during the inspection or field test, while preparing FDA-483 and EIR or field test reports, and in classifying the inspection or field test and recommending follow-up.

B. DISTRICT RESPONSIBILITIES

1. Reporting inspection and test findings

1. Inspection reports
   Provide a copy of the completed inspection and test record used during the inspection along with the Establishment Inspection Report (EIR) and exhibits. Refer to the IOM for EIR formats, and clearly indicate the scope of the inspection in the EIR. Document any corrections performed during the inspection or corrections promised with the timeframe for completion.
2. Field test reports
   Provide a copy of the completed field test record along with a summary of findings.

2. Recommending Action

A table of violations and their health and safety risk as well as the nature of the regulatory response has been provided for each product area.

1. Hazard Class for Non-Compliance
   Class A, B, C, and D refer to the hazard class of the observations, related to the severity of the threat to health and safety posed by a particular non-compliant product or practice.
   • Class A: Conditions that pose an immediate radiation hazard to health and safety. Notify CDRH/OCER contacts identified in Part VI of this program immediately to discuss appropriate action to stop production or product use until corrective action has been taken. Consider contacting State Health Department or other local contacts to assist in addressing problems with product use, if warranted.
   • Class B: Conditions that include radiation safety defects or items of noncompliance with the standard which, without corrective action, could pose a radiation hazard if the non-compliance or defect is not addressed.
   • Class C: Labeling or user information fails to comply with a standard.
   • Class D: No problems found.
      
2. Regulatory Response to Non-Compliance
   The designations of a violation as Major, Minor, or Concern refer to the level of regulatory response required to correct deficiencies.
   • Major: Non-compliance with a standard that always warrants regulatory action such as a warning letter.
   • Minor: Non-compliance with a standard about which a manufacturer should be informed but is not severe enough to warrant a warning letter.
   • Concern: Non-compliance which is not severe enough to mention unless also informing a manufacturer about a Major or Minor item.
      
3. Inspection Classification
   Based on inspectional findings, the district will classify the inspection as OAI, VAI or NAI for further action.
    
   If any major EPRC deficiencies exist, the district is expected to classify the inspection as OAI and recommend further regulatory action. Examples of findings that would result in an OAI classification include:
   • Total failure to establish a quality control testing program capable of ensuring radiation safety of the product or compliance with applicable performance standards.
   • Any single observation of a major deficiency listed in the specific product non-compliance tables contained in Attachments A – F of this program
   • Several observations consisting of minor deficiencies listed in Attachments A – F of this program

The inspection may be classified VAI for a limited number of minor deficiencies listed in Attachments A – F and further regulatory action will be pursued at the discretion of the district and CDRH.

If it is determined that the EPRC deficiencies are of a quantity and type to conclude there is minimal probability that the firm will produce unsafe or noncompliant products, the inspection will be classified NAI and Form FDA-483 will serve to inform the firm of any objectionable findings. Deficiencies identified as violations of concern will generally not require additional follow-up but should be discussed with the firm.

Consult CDRH if additional guidance is required to classify inspection and test observations. If the inspection also covered firm compliance with medical device Quality Systems requirements, Compliance Program 7382.845, Part V, Quality System/GMP Regulatory/Administrative Follow-Up, should be consulted for appropriate regulatory and administrative follow-up.

C. REGULATORY ACTION

In determining appropriate regulatory action based on inspection and test findings, the district and CDRH should consider the significance of the product, the firm’s history, whether the problem is widespread and continuing. Actions which may be considered include notification of noncompliance letters (warning and untitled letters), product repurchase, repair or replacement (recall), civil penalties and injunctions, and seizures (for radiation-emitting medical devices).

1. Notification of noncompliance letters (Warning and Untitled Letters)

The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1003) require the Agency to notify manufacturers in writing when product noncompliance with a standard is found. Manufacturers may also be advised in writing of a failure to comply with reporting and recordkeeping requirements (21 CFR 1002.31). A table classifying the severity of items of noncompliance with reporting and recordkeeping, and performance standard requirements is included in Attachments A – F.

Issuance of all letters should follow Chapter 4 of the Regulatory Procedures Manual (RPM) http://www.fda.gov/ora/compliance_ref/rpm/. Consult the Office of Enforcement’s (OE) Warning Letter page on ORA’s intranet for current instructions for obtaining Office of Chief Counsel (OCC) clearance and for current approved Warning Letter templates. Letter templates must be used to satisfy Agency notification requirements in 21 CFR 1003.11. Where approved OCC templates are not available, consult CDRH for the current version of letter templates.

Districts have DIRECT REFERENCE AUTHORITY for EPRC letters in certain areas which are described in Chapter 4 of the RPM. For example, districts have direct reference authority to issue sunlamp product warning and untitled letters, to grant exemption from notification, and approve manufacturer corrective action plans, which are further described in Attachment C of this program. CDRH is available for consult in assessing product noncompliance or developing regulatory and enforcement strategy.

For the majority of cases, where districts DO NOT have direct reference authority to issue EPRC letters, forward the report with exhibits and recommended action to CDRH for review and follow-up. CDRH will copy the accomplishing district on any letters issued and consult on regulatory and enforcement strategy when needed.

1. Major Notification of Noncompliance Letter (Warning Letter)
   This letter notifies the firm of major items of noncompliance and requires the firm to further notify purchasers and recall products. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval.
    
   Issue a major notification (warning) letter when the violation of the standard requires further regulatory action.
   • All major violations must be addressed in a warning letter.
   • Firms and products with several minor violations may also be issued a major notification letter, depending on the public health significance of the violation(s) and the number of products involved.
   • Violations of concern may also be included in a major notification (warning) letter, but would not warrant issuance of a major notification (warning) letter on their own merit.
      
   The firm’s quality control testing program may be also be disapproved upon issuance of a major notification letter, when the Agency believes that the manufacturer’s quality control and testing program is not following good manufacturing practices. A program disapproval orders the manufacturer to cease certification of products (i.e. stop production and testing) until the program disapproval is rescinded, and places the firm’s products on automatic import detention without prior examination, under authority of Section 534(h) of the Act and 21 CFR1010.2 of the regulations. A program disapproval may be issued only by CDRH.
    
2. Minor Notification of Noncompliance Letter (Untitled Letter)
   This letter notifies the firm of minor items of noncompliance and exempts the firm from further notifying purchasers and recalling products. The firm is instructed to address all items in the letter and make appropriate corrections for future production.

   Issue a minor notification (untitled) letter when the violation of the standard does not justify further regulatory action at the time.

   • Firms and products with a limited number of minor violations may be issued a minor notification letter, depending on the public health significance of the violation(s) and the number of products involved.
   • Violations of concern may also be included in an untitled letter, but would not warrant issuance of an untitled letter on their own merit.

2. Repurchase, Repair, or Replacement of Electronic Products (Recall)

The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1004) also provide for manufacturer repurchase, repair or replacement of the noncompliant electronic products.

Every major notification of noncompliance letter issued as a result of a major violation or several minor violations requires manufacturer repurchase, repair or replacement of the affected electronic products at no cost to the purchaser. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval. Refer to RPM Chapter 7, Attachment E for approval of manufacturer's corrective action plans.

3. Refutation or Exemption from Notification or Correction Requests

Manufacturers can refute the noncompliance or be granted an exemption, by making a written request to CDRH. The exemption can be granted upon request by the manufacturer or by the Agency at its own initiative, and must show that the noncompliance does not create a significant risk of injury.

Within 15 days after notification of the noncompliance/defect by FDA, a manufacturer may refute the alleged noncompliance under 21 CFR 1003.11(a)(3) or request an exemption from purchaser notification and correction as specified under 21 CFR 1003.30. If a manufacturer refutes the alleged noncompliance, or requests an exemption, the evidence presented by the manufacturer is evaluated by CDRH before granting or denying the request for exemption or responding to the refutation. Refer to RPM Chapter 7, Attachment E for information on responding to exemption requests and refutations.

4. Timeframes for action

Immediately notify CDRH and State and local health authorities (through RRHR) for any Class A hazard.

For all inspections and tests that may require issuance of a letter, the EIR should be provided to CDRH or the district compliance officer to allow sufficient time to review, draft, and secure approval for the letter. Timeframes for clearance of letters are provided in Chapter 4 of the RPM.

5. Civil Penalties/Injunctions

Civil penalties should be recommended for violations of Subchapter C of the Act after other actions have failed to achieve compliance, or for knowing and willful violations. More severe civil penalty assessments may be sought under Section 303(f). See CPG Sec. 390.300 and RPM Chapter 6, Civil Penalties - Electronic Product Radiation Control. Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged in order to facilitate timely implementation of the action; contact Electronic Products Branch Chief or Lead CSO at (240) 276-3332.

If an establishment has a continuing pattern of significant deviations in spite of past warnings, injunction will usually be the recommended action of choice. If a serious health hazard exists, the recommendation should include a request for a temporary restraining order (TRO) to prevent the distribution of products that have been manufactured under the violative conditions documented by the inspection report per the instructions in Chapter 6 of the RPM. Civil penalties and injunctions may be recommended concurrently.

6. Detention/Seizure

Use administrative detention and recommend seizure of a defective or noncompliant radiation-emitting medical device if all three conditions below apply:

• There is a Class A health hazard
• The owner/operator refuses to remove the product from service or returns the product to use before the Class A hazard is corrected
• The EPRC provisions are ineffective in achieving timely correction by the manufacturer

Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged; contact Electronic Products Branch Chief or Lead CSO at (240) 276-3332.

D. FEDERAL/STATE RELATIONS

Some states have Radiation Control Programs within the State Health Department or Department of Environmental Health, which may have adopted portions of the EPRC requirements into their radiation safety regulations.

Districts should use all reasonable means available to encourage voluntary conformance of products with the performance standard regardless of the date of manufacture. It is recommended that the districts coordinate regulatory activity with appropriate state representatives through the RRHR and DFSR, particularly where local authority may assist in achieving correction of a deficiency. This may be particularly useful to address issues related to product use where the State may have regulatory authority, which extends beyond FDA authority to regulate the design, production or manufacture of the product.

E. MEDICAL DEVICE REGULATORY/ADMINISTRATIVE FOLLOW-UP

Regulatory follow-up for joint EPRC/quality systems inspections can be handled separately or in combination at the discretion of the district and CDRH. Refer to Part V in Compliance Program 7382.845, Quality System/GMP Regulatory/Administrative Follow-Up, for guidance on regulatory actions related to radiation-emitting medical devices. Enforcement actions on radiation emitting medical device firms, which also include EPRC violations, require CDRH concurrence before implementation by the field. Contact CDRH for consultation when both EPRC and quality systems violations are noted during an inspection or field test.

PART VI REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

A. REFERENCES

1. Law

Federal Food, Drug, and Cosmetic Act, As Amended
Electronic Product Radiation Control Provisions (formerly known as the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 0ctober 18, 1968)
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

2. Regulations

21 CFR 1000 – 1005, General Requirements for All Electronic Products which Emit Radiation
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1005

21 CFR 1010, Performance Standards for Electronic Products: General
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1010

21 CFR 1020 – 1050, Specific Performance Standards for Electronic Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1020&CFRPartTo=1050

3. Regulatory Procedures Manual (RPM)

http://www.fda.gov/ora/compliance_ref/rpm/default.htm

4. Investigations Operations Manual (IOM) - Chapter 5

http://www.fda.gov/ora/inspect_ref/iom/default.htm

5. FDA Web Sites

FDA home page
http://www.fda.gov

ORA home page
http://www.fda.gov/ora/

CDRH home page
http://www.fda.gov/cdrh/

Field Accomplishments and Compliance Tracking System (FACTS)
(visit ORA’s home page, then click the FACTS icon.)

Electronic Product Radiation Control home page
http://www.fda.gov/cdrh/radhealth

Product Code Classification Database (searchable)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesearch.cfm

Good Guidance Practices Database (searchable)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm

B. ATTACHMENTS

1. Attachment A – Classification table for reporting and quality control testing program Non-Compliant Items (common to all EPRC inspections and field tests)
2. Attachment B – Specific Instructions for Laser Product Inspections and Tests
3. Attachment C – Specific Instructions for Sunlamp Product Inspections and Tests
4. Attachment D – Specific Instructions for Cabinet X-Ray Product Inspections and Tests
5. Attachment E – Specific Instructions for Television Product Inspections and Tests
6. Attachment F – Specific Instructions for Microwave Oven Product Inspections and Tests

C. PROGRAM CONTACTS

Center for Devices and Radiological Health

Office of Communication, Education and Radiation Programs, Division of Mammography Quality and Radiation Programs (DMQRP)

Contact for support in planning and executing inspections and field tests, classification of items of non-compliance, and for interpretation and current policy on EPRC requirements. Send all inspection and test reports to Chief, Electronic Products Branch, FDA/CDRH Office of Communication, Education and Radiation Programs (HFZ-240), 1350 Piccard Drive, Rockville, MD 20850.

Office of Science and Engineering Laboratories

Contact for assistance with identifying appropriate instrumentation for use in measuring electronic product radiation emissions.

Office of Regulatory Affairs

Field Regional Radiological Health Representatives

Field Electro-Optics Specialists and laser product contacts

Winchester Engineering and Analytical Center contacts

Headquarters contacts

Attachment A: Classification table for reporting and quality control testing program Non-Compliant Items

The following items are common to all EPRC inspections and field tests, and may be cited for any product subject to the below reporting or certification requirements. Products subject to reporting are listed in Table 1 of 1002.1, and certification requirements are applicable to all products subject to a performance standard.

Attachment B: Specific Instructions for Laser Product Inspections and Tests

Background

The Laser Products Performance Standard (the standard), promulgated in August 1976, was designed to protect the public from unnecessary radiation hazards associated with the use of these products. The radiation emitted from these laser products can pose varying degrees of hazards depending upon the type, magnitude, and accessibility of the radiation and upon the particular functions or operations they perform. The standard was last amended in 1985. Since then, the CDRH has intended to harmonize the requirements of the standard with those of the international standard IEC 60825-1: 2001. As an interim step the CDRH published its Laser Notice 50 in 2001 stating that it would not object to compliance with specified requirements of the international standards in lieu of comparable requirements of the CDRH standard.

Specific Instructions

High-risk laser products and their manufacturers should be inspected or tested as a priority. Examples of high-risk laser products and manufacturers include:

• Class IIIb and IV medical lasers (e.g. surgical)
• Class IIIb and IV industrial lasers used in material processing
• Class IIIb and IV lasers used in law enforcement or military applications
• Manufacturers with known or suspected problems based on previous inspection, field tests or complaints
• New manufacturers not yet inspected
• Manufacturers introducing new technology to the US market
• Manufacturers with a large potion of the US market share for any laser product. Class I low risk laser products, such as optical disk drives or laser printers, should not be inspected or tested.

Electro-optics specialists have been specifically trained in general EPRC requirements and also have specialized training in the laser product performance standards. EOS’s should perform these inspections and field tests, and may train additional field staff or accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an EOS has training in both EPRC and QSIT inspections, a single EOS may conduct both portions of the inspection.

CDRH is responsible for review of laser manufacturer inspection and product field test observations and initiating administrative or regulatory follow-up.

References

Frequently Asked Questions about Lasers.
http://www.fda.gov/cdrh/radhealth/products/laserfaq.html

Performance Standard-Lasers and Products Incorporating Lasers
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.10

Performance Standard-Specific Laser Products (Includes Display, Survey, and Medical Laser Products)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.11

Laser Compliance Guide
http://www.fda.gov/cdrh/radhlth/pdf/lasgde01.pdf

Reporting Guide-Radiation Safety Product Report for Laser Products
http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf

Reporting Guide-Radiation Safety Product Report for Laser Light Shows/Displays
http://www.fda.gov/cdrh/radhlth/pdf/llsrpt01.pdf

Laser Quality Control Guide
http://www.fda.gov/cdrh/radhlth/pdf/lasgdeqc.pdf

Refer to the laser products main page for guidance documents and additional information:
http://www.fda.gov/cdrh/radhealth/products/lasers.html.

Laser Product Codes

Classification of Non-compliant Items

Sample Laser Product Inspection and Field Test Checklist

LASER PRODUCT TEST RECORD

MANUFACTURER____________________ CLASS____________

MODEL_______________________ SERIAL NUMBER_______

Status of Unit Examined (Circle one): Prototype/Production unit

Status of Assembly (circle one): Complete/Incomplete

Manufactured Date:_________________________

A. Product Description: (Include basic configuration and size of product, reference to photos and/or
diagrams, basic functions to be performed during operation and during maintenance.)

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

Yes_________ No_________

If yes, what is the Accession Number? _____________________________

Summary of Product Evaluation:

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

1. Certification label (1010.2)

a. Is the label permanently affixed? Yes___ No___ ND___ NA___

b. Is the Label readily viewable? Yes___ No___ ND___ NA___

Location:______________________

c. Is the label properly stated? Yes___ No___ ND___ NA___

(Note: Products under variance require modified certification labels 1010.4(d))

d. Remarks: ________________________________________________

__________________________________________________________

2. Identification label (1010.3)

a. Is the label permanently affixed? Yes___ No___ ND___ NA___

b. Is the label readily viewable? Yes___ No___ ND___ NA___

Location: _______________________

c. Does the label contain the full name and address?

Yes___ No___ ND___ NA___

d. Does the label contain the place of manufacture (in full or in code)?
Yes___ No___ ND___ NA___

e. If coded, has CDRH been provided the code?
Yes___ No___ ND___ NA___

f. Are the month and year of manufacture stated in full?*

Yes___ No___ ND___ NA___

Month and year: __________________________

g. Remarks:____________________________________________________

____________________________________________________________

*Note: Serialization is acceptable in lieu of month and year for consumer electronic products.

D. Special Purpose Products (1040.11)

1. Is the product a medical laser product?

Yes___ No___ ND___ NA___

Note: In inspecting manufacturers of not only medical laser products but also laser products that are medical devices, verify compliance with other applicable requirements including but not limited to current registration and listing, 510k market clearances, device master record or quality system, current complaint and service records, etc.

a. Does the product include a means of measurement of levels of radiation intended for irradiation of the human body?

Yes___ No___ ND___ NA___

b. How is this accomplished? Measure beam prior to delivery system and determine output levels via calibration constant _________;
Measure output of delivery system ___________;
Other ___________.

c. Indication: power ________; energy________; time _______.

d. Type of indicator: energy/power select switch ___; "Test shot" display (remains constant until next best shot) ___; Real time display (displays level at all times) ___; Other ___.

e. If test shot is available only at initiation of procedure or if a select switch is used, does the product have an internal monitoring system capable of maintaining output levels to within ± 20% of displayed value?
Yes ___ No___

f. Is display analog ____; or digital ____? If digital, are there sufficient significant digits to allow ± 20% accuracy? Yes ___ No ___

g. Is the total measurement error within ± 20% (see Attachment G) Yes___ No___ ND___ NA___

h. Is there a laser aiming beam? Yes ___ No ___. Is there a means to measure the level of the aiming beam if the product is ophthalmic and the aiming beam may exceed 1 mW or if the product is not ophthalmic but the aiming beam may exceed 5 mW?
Yes ___ No ___

i. Remarks: _____________________________________________________

_____________________________________________________________

2. Is the product a surveying, leveling, and alignment product?

Yes___ No___ ND___ NA___

a. Is access prevented for wavelengths of 400 nm to 710 nm to radiation power in excess of 5.0 mW for any duration greater than 3.8 x 10-4 seconds?

b. Is access prevented to radiation levels in excess of Class I limits for any other combination of emission Duration and wave length range?

Yes___ No___ ND___ NA___

c. Remarks: ____________________________________________________

____________________________________________________________

3. Is the product a demonstration laser product?
Yes___ No___ ND___ NA___

a. Does the product prevent human access to radiation in excess of the Class IIIa (3R) limit?
Yes___ No___ ND___ NA___

b. Remarks: ____________________________________________________

____________________________________________________________

E. Label Requirements. See instruction in paragraph B.

1. Warning logotypes* (1040.10(g)(1),(2),(3),(4),(5),(9), and (10)

a. Is the logotype the correct logotype?
Yes___ No___ ND___ NA___

b. Is the label properly worded for its class designation?

Yes___ No___ ND___ NA___

c. Does the label have the proper color?

Yes___ No___ ND___ NA___

d. Is the output information present and correct?

(Maximum output stated ________.) Yes___ No___ ND___ NA___

e. Is the media or wavelength information present and correct?

Yes___ No___ ND___ NA___

f. Is the label permanently affixed and clearly visible during operation, maintenance, and
service?
Yes___ No___ ND___ NA___

g. Is the label positioned so as to make exposure unnecessary during reading?
Yes___ No___ ND___ NA___
Location: ____________________

h. Does the label include a warning for "invisible" or "invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

i. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

Note: Warning labels in accordance with IEC 60825-1 including product classification are acceptable.

2. Aperture label (for Classes II, IIIa, IIIb, IV, 3R, 3B and 4) 1040.10(g)(5),(8),(9), and (10)

a. Is a label present and in proximity to each aperture?

Yes___ No___ ND___ NA___

b. Is the label properly worded? Yes___ No___ ND___ NA___

c. Is the label permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

d. Is the label positioned so as to make exposure unnecessary during reading?
Yes___ No___ ND___ NA___

(Location: ______________)

e. Does the label include a warning for "invisible" or "invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

f. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

3. Noninterlocked protective housing label (1040.10(g)(6),(8),(9), and (10)

a. Are the labels on or near all appropriate panels or covers which are removed for operation, maintenance, or service?

Yes___ No___ ND___ NA___

b. Are all labels visible prior to removal of such portions of the protective housing?
Yes___ No___ ND___ NA___

c. Are all labels visible after opening?
Yes___ No___ ND___ NA___

d. Are all labels correctly worded? Yes___ No___ ND___ NA___

e. Are all labels permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

f. Do all labels contain a warning for "invisible" or "invisible and/or visible" radiation? Yes___ No___ ND___ NA___

g. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

4. Defeatably interlocked housing labels 1040.l0(g)(7),(8),(9), and (10)

a. Are labels provided for each defeatably interlocked panel or cover which is removed for operation, maintenance, or service?

Yes___ No___ ND___ NA___

b. Are all labels visible prior to interlock defeat?

Yes___ No___ ND___ NA___

c. Are all labels visible during interlock defeat?

Yes___ No___ ND___ NA___

d. Are all labels correctly worded?

Yes___ No___ ND___ NA___

e. Are all labels permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

f. Do all labels contain a warning for "invisible" or invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

g. Remarks: _____________________________________________________

_____________________________________________________________

F. Performance Requirements (1040.l0(f)):

1. Protective Housing (1040.l0(f)(l))

a. Does the housing prevent access at all times to laser radiation above Class I not necessary for operation of the product?

Yes___ No___ ND___ NA___

b. Does the housing prevent access at all times to collateral optical radiation above Class I not necessary for operation of the product?
Yes___ No___ ND___ NA___

c. Has x-radiation been evaluated?
Yes___ No___ ND___ NA___

d. Does the housing prevent access to x-radiation levels in excess of 0.5 mR/hr at all times during operation of the product?

Yes___ No___ ND___ NA___

e. Remarks: _____________________________________________________

_____________________________________________________________

2. Safety Interlocks (1040.10(f)(2)) (Complete for each interlock. Identify the portion of
removable or displaceable housing and interlock described.)

a. Do operation or maintenance functions require moving portions of the housing which could allow access to radiation?

Yes___ No___ ND___ NA___

Describe: _____________________________________________________

_____________________________________________________________

b. Class of radiation to which access could be gained?
Class ______.

c. Is a fail safe or multiple interlock required (including 1040.l(f)(2)(iii)?

Yes___ No___ ND___ NA___

Where? ______________________________________________________

_____________________________________________________________

d. Are safety interlock(s) present? where?_______________

1. TYPE: Microswitch____; Mercury switch____;
male-female plug____; mechanical shutter____; other____.

Describe: _____________________________________________

e. Method of limiting access: directly interrupts primary laser power____; interrupts primary laser power through relay, contactor, switching tube or transistor____; spoils the cavity____; shutter beam via solenoid____; other____.

f. Is there a multiple or fail safe interlock on each housing for which an interlock is required?

Yes___ No___ ND___ NA___

g. Is the interlock defeatable? Yes___ No___ ND___ NA___

h. Is there an indication of defeat? Yes___ No___ ND___ NA___

Describe: _______________________________________________________

i. Does the interlock preclude replacement of the housing while the interlock is defeated?
Yes___ No___ ND___ NA___

j. Are non-safety interlocks present? Where?_____________

Yes___ No___ ND___ NA___

k. Remarks: _________________________________________________

_________________________________________________________

3. Remote Interlock Connector (1040.l0(f)(3), Class IIIb or IV systems only)

a. Is a remote control connector present?

Yes___ No___ ND___ NA___

b. Type? Describe: ________________________________________

c. Is the voltage across the connector less than 130 volts RMS?

Yes___ No___ ND___ NA___

d. Is the access to laser and collateral radiation prevented when the terminals are not joined?
Yes___ No___ ND___ NA___

e. Method of operation: Directly interrupts laser power____; interrupts laser power through relay, etc.____; shutters beam or interrupts cavity____.

f. Does the emission delay reactivate when the remote control circuit is interrupted?
Yes___ No___ ND___ NA___

g. Must the emission be manually restarted following interruption via the remote interlock connector?

Yes___ No___ ND___ NA___

h. Remarks: ____________________________________________________

____________________________________________________________

4. Key Control (1040.10(f)(4), Class IIIb, IV, 3B, or 4 systems only)

a. Is a key control present? Yes___ No___ ND___ NA___

Describe: ___________________________________________________

_____________________________________________________________

b. Is a key removable in the "on" position?

Yes___ No___ ND___ NA___

c. Is operation prevented when the key is removed?

Yes___ No___ ND___ NA___

d. How? ____________________________________________________

____________________________________________________________

e. Remarks: _________________________________________________

____________________________________________________________

5. Beam Attenuator (1040.l0(f)(6), Class IIIb, IV, 3B or 4 systems only)

a. Is a beam attenuator present? Yes___ No___ ND___ NA___

b. Type: mechanically operated shutter____; electrically operated____; aperture cap or cover____; other____.

Describe: ___________________________________________________

____________________________________________________________

c. Is the attenuator permanently attached?

Yes___ No___ ND___ NA___

d. Does the attenuator prevent access by any part of the body to radiation in excess of Class I limits?

Yes___ No___ ND___ NA___

e. If there is no beam attenuator, has the manufacturer requested and obtained approval of an alternate means of safety?

Yes___ No___ ND___ NA___

f. Remarks: _________________________________________________

_____________________________________________________________

6. Emission Indicator (1040.10(f)(5), Class, IIIb, IV, 3B or 4 Systems only)

a. Is an emission indicator present on the laser product?

Yes___ No___ ND___ NA___

Where? ________________________________________________

b. Type: tungsten lamp(s)____; neon lamp(s)____; LED(s)____; other____.

Describe: _________________________________________________

_______________________________________________________

c. If the indicator is visible, is it visible through the protective eyewear that is normally supplied or recommended?

Yes___ No___ ND___ NA___

d. Can the indicator be viewed without exposure to radiation in excess of Class I limits?

Yes___ No___ ND___ NA___

e. Is there a delay between an indication of emission and the beginning of emission?
Yes___ No___ ND___ NA___

f. How is emission delay achieved? Thermal relay___; inherent in the lasing process___; delay circuit___; other___.

Describe: ________________________________________________

_________________________________________________________

g. Length of delay? ____________________

h. Is the power source or operation control separable from the laser by greater than 2 meters when assembled for use?

Yes___ No___ ND___ NA___

i. If separated greater than 2 meters, is an emission indicator present on the energy source or controller?
Yes___ No___ ND___ NA___

Where? _____________________________________________________

j. Type: Tungsten lamp(s)___; neon lamp(s)___; LED(s)___; bell or buzzer___; meter or display___; mechanical flag___; other___.

Describe: ______________________________________________

______________________________________________________

k. Is there a delay between an indication of emission and the beginning of emission?
Yes___ No___ ND___ NA___

l. How is emission delay achieved? Thermal relay___; inherent in the lasing process___; delay circuit___; other___.

Describe: ______________________________________________

______________________________________________________

m. Length of delay? ____________________________________________

n. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

6. Location of Controls (1040.10(f)(7))

a. Are the controls located so that exposure is unnecessary for operation or adjustments?
Yes___ No___ ND___ NA___

b. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

7. Viewing optics (1040.l0(f)(8))

a. Are viewing optics or viewports present?

Yes___ No___ ND___ NA___

b. Type: microscope___; telescope___; viewport___; display screen___; other___.

Describe: ___________________________________________________

____________________________________________________________

____________________________________________________________

c. Where? ___________________________________________________

____________________________________________________________

d. Do the viewing optics attenuate radiation at all times during operation or maintenance to levels less than Class I limits?

Yes___ No___ ND___ NA___

e. Do the viewing optics employ a shutter or variable attenuator?

Yes___ No___ ND___ NA___

f. Upon failure of the shutter of the variable attenuator is access to radiation levels greater than the Class I limits prevented?
Yes___ No___ ND___ NA___

g. Remarks: _________________________________________________

____________________________________________________________

____________________________________________________________

8. Scanning Safeguard (1040.10(f)(9))

a. Is the radiation emitted by the product scanned?

Yes___ No___ ND___ NA___

b. Is the classification of the product based on the level of scanned radiation?
Yes___ No___ ND___ NA___

c. In the event of scan failure, is human access to laser radiation in excess of the product class prevented?

Yes___ No___ ND___ NA___

d. Remarks: _________________________________________________

_____________________________________________________________

9. Manual Reset Mechanism (1040.l0(f)(l0) Class IV laser systems)

Describe the operation of the Manual Reset. ___________________

____________________________________________________________

How is it achieved? (latching relay, etc.) ________________

____________________________________________________________

10. Removable laser system (1040.10(c)(2))

a. Does the product incorporate a laser system?

Yes___ No___ ND___ NA___

b. Is the laser system removable?
Yes___ No___ ND___ NA___

c. If removable, is the laser system independently certified?

Yes___ No___ ND___ NA___

d. If not removable, specify how removability is prevented: hard wiring___; modified connector___; assembled internally from components___; other (specify). __________________________

e. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

G. Laser Product Measurements

Model # ________________________ Serial # _______________________

Manufacturer's Claimed Classification: ___________________________________

Brief description of product: ___________________________________________

___________________________________________________________________

___________________________________________________________________

Test Instrument(s) Used: _______________________________________________

___________________________________________________________________

Circle radiometric quantity tested and specify units below (Radiance (W cm-2 sr-1), Radiant Energy (J), Power (W), etc.)

Calculations (as needed):

__________________________________________________________________

__________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

H. Results of FDA measurements: ______________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

I. Compliance with other requirements (e.g., conditions of a variance, labeling for medical devices, etc.)

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

J. Information requirements (Directions: Complete this section only if the information and requirements are reviewed during the inspection).

1. User Information (1040.l0(h)(l))

a. Does the manual contain adequate instructions for assembly,
operation, and maintenance? Yes___ No___ ND___ NA___

b. Does it contain clear warnings to avoid exposure?

Yes___ No___ ND___ NA___

c. Does it contain a statement of output parameters?

Yes___ No___ ND___ NA___

d. Does it contain legible reproductions of all labels and hazard warnings?
Yes___ No___ ND___ NA___

e. Does it include the corresponding position of each label on the product?
Yes___ No___ ND___ NA___

f. Does it contain listing of controls, adjustments, and procedures for operation and maintenance?
Yes___ No___ ND___ NA___

g. Does it contain a schedule of maintenance?

Yes___ No___ ND___ NA___

h. Does it contain the "Caution - use of controls..." warning?

Yes___ No___ ND___ NA___

i. Does it contain a compatibility statement (laser source or laser system not supplied with the product?

Yes___ No___ ND___ NA___

j. Does it contain a calibration schedule (medical laser product)?
Yes___ No___ ND___ NA___

k. Does it include a warning not to point the laser radiation at the audience (especially Class IIIa demonstration laser products)?
Yes___ No___ ND___ NA___

l. Does it include information to determine nominal hazard zone(class IV multi-axis workstations)?
Yes___ No___ ND___ NA___

m. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

2. Purchasing Information (1040.10(h)(2))

a. Are legible reproductions of the logotype required to be affixed to the product (including information required for positions 1, 2, and 3) contained in catalogues, specification sheets, and descriptive brochures?
Yes___ No___ ND___ NA___

3. Servicing Information (1040.l0(h)(2))

a. Are adequate instructions for service adjustments and service procedures available?
Yes___ No___ ND___ NA___

b. Are clear warnings and precautions to avoid possible exposure included?
Yes___ No___ ND___ NA___

c. Is a schedule of maintenance necessary to keep the product in compliance included?
Yes___ No___ ND___ NA___

d. Are controls and procedures which would he used by reasons other than the manufacturer or his agent to increase accessible emission levels listed?
Yes___ No___ ND___ NA___

e. Is a clear description of the locations of displaceable portions of the protective housing provided?
Yes___ No___ ND___ NA___

f. Do these instructions provide legible reproductions of required labels and hazard warnings?
Yes___ No___ ND___ NA___

g. Do these instructions include protective procedures for service personnel?
Yes___ No___ ND___ NA___

h. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests

Background

A sunlamp product is an electronic product designed to use one or more ultraviolet lamp(s) and is intended for irradiation of any part of the living human body by ultraviolet radiation within a specified range of wavelengths to induce skin tanning. The ultraviolet lamps, subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.

Sunlamp products include portable home units, table top models, tanning beds and tanning booths. These units may incorporate different types of fluorescent lamps, reflector spot (RS) or High Intensity Discharge (HID) with different levels of energy output and radiation at different wavelengths.

Since sunlamp products are radiation-emitting electronic products as defined by Section 531 of Subchapter C- Electronic Product Radiation Control (EPRC) formerly the Radiation Control for Health and Safety Act (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA, the Act), they are regulated under both laws.

Under authority of Section 534 of the (EPRC), a performance standard for sunlamp products and ultraviolet lamps intended for use in these products was promulgated effective May 7, 1980 (21 CFR 1040.20). The standard was intended to reduce sunlamp related injuries by reducing unnecessary exposure and overexposure to sunlamp radiation by: (1) limiting shorter wavelength emissions that are not necessary and pose unreasonable risk, (2) providing for adequate warning label and user instructions containing safety information, and (3) requiring special lamp bases, protective eyewear, timers, and controls to help users limit the duration and amount of exposure.

This performance standard was promulgated when the common sunlamp product was a table-top, home portable unit incorporating one or two RS lamps having a large part of their radiation output in the wavelength range of 260 to 320 nanometers (UVB). In 1979-80, a new-wave of sunlamp products came onto the market. These products, commonly referred to as Tanning Booths, usually measured 3'x3'x7' and contained one or two fluorescent ultraviolet lamps in each corner. These products also had relatively high UVB output.

Around early 1983, another product in the shape of a bed and/or canopy entered the market with fluorescent lamps that emit radiation mainly in the 320-400 nanometer range (UVA), with usually less than 5% in-the UVB range. This type of product requires longer exposure times to achieve its intended purpose and the risk of chronic sunburn is reduced relative to the older type of products. Most manufacturers requested variance under 21 CFR 1010.4 to equip the products with timers which would allow exposure in excess of ten minutes. Since the products usually required 30 minutes to achieve their intended result, the variances were granted with two conditions: (1) the maximum timer interval shall not exceed the maximum recommended exposure time specified in the required product label, and (2) the UVB to UVA ratio shall not exceed .05 (no more than 5% UVB). The manufacturers are required to specify the variance number and effective date on the product).

Some of these products incorporate High Intensity Discharge (HID) lamps. These lamps are usually used for facial tanning, although some whole body exposure systems use such lamps exclusively. In most cases, however, these lamps are used in conjunction with ultraviolet fluorescent lamps. The HID lamps are much smaller than fluorescent lamps, (usually about 1/2" in diameter by 3" in length) and they usually incorporate an outer, clear, glass envelope.

On September 6, 1985, amendments to the performance standard were published and became effective in September 8, 1986. The purpose of the amendments is to accommodate new products employing design concepts significantly different from those for which the original standard was developed. Also, FDA experience in applying the original standard indicated that some requirements were either inappropriate for or not applicable to some products. The amendments are intended to establish a standard that is appropriate for the present technology of tanning and new sunlamp product designs. This revised program offers guidance for testing products against the original standard or revised standard, as appropriate.

Specific Instructions

Some electro-optics specialists, x-ray auditors and other radiological health specialists have been trained in general EPRC requirements and also may have specialized training in the sunlamp product performance standards. Only trained individuals should perform these inspections and field tests and may train additional field staff or accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an EOS has training in both EPRC and QSIT inspections, a single EOS may conduct both portions of the inspection.

The District Offices have the authority (delegated under 21 CFR 5.37 and 5.89) to make declarations of noncompliance and/or defect for sunlamp products. The field also has the authority to approve sunlamp manufacturer corrective action plans under 21 CFR 1004 and to grant exemptions (from notification and product repair) in accordance with 21 CFR 1003.31. Consult CDRH for assistance in determining appropriate enforcement action or other support. A copy of any letter issued to a manufacturer must be sent to HFZ-240.

References

Sunlamp Products, Performance Standard – 21 CFR 1040.20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.20

Quality Control Guide for Sunlamp Products. (Publication; FDA 84-8234)
http://www.fda.gov/cdrh/radhlth/pdf/SUNQCG.pdf

Policy on Warning Label Required on Sunlamp Products (6/25/85)
http://www.fda.gov/cdrh/radhlth/pdf/sunpol01.pdf

Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products (8/21/86)
http://www.fda.gov/cdrh/radhlth/pdf/sunpol01.pdf

Policy on Lamp Compatibility (9/2/86).
http://www.fda.gov/cdrh/radhlth/pdf/sunpollc.pdf

Sunlamp Products Reporting Guide, (dated September, 1995).
http://www.fda.gov/cdrh/radhlth/pdf/sunrpt0p.pdf 

Refer to the sunlamp products main page for additional information:
http://www.fda.gov/cdrh/radhealth/products/sunlamps.html

Sunlamp Product Codes

Classification of Non-compliant Items

Sample Sunlamp Product Inspection and Field Test Checklist

INSPECTIONAL FIELD TEST CHECKLIST REPORT FOR SUNLAMP PRODUCTS
MANUFACTURED AFTER SEPTEMBER 8, 1986
(Including Pertinent Parts of the Regulation)

WARNING LABEL [21 CFR 1040.20(d)(1)]

Accessible To View: Yes / No Legible From One Meter: Yes / No Exposure Position: Yes / No "DANGER" Statement:: Yes / No

If "NO" to any of the above, Explain:___________________________________________________________________________________

Exposure Schedule times: Minimum ____min. / Maximum ____min. Warning Label Location:_________________________________

List All Lamp Types Designated On Unit Labeling:_________________________________________________________________________

CERTIFICATION LABEL [21 CFR 1040.20(d) & 21 CFR 1010.2]

Adequate Certification: Yes / No Written In English: Yes / No Legible: Yes / No

If "NO" to any of the above, Explain:___________________________________________________________________________________

IDENTIFICATION LABEL [21 CFR 1040.20(d) & 21 CFR 1010.3] (AS APPEARS ON LABEL)

Name & Address of Manufacturer:______________________________________________________________

Model #:_______________________________ Serial #:_______________________ Date of Manufacture:___________________________

PROTECTIVE EYEWEAR [21 CFR 1040.20(C) (4)]

Maximum Number of Users for Sunlamp Product:__________

Number of pairs:___________ Model Type:_________________________ Manufacture:_______________________________________

Number of pairs:___________ Model Type:_________________________ Manufacture:_______________________________________

LAMPS IN UNIT [21 CFR 1040.20(d) (1) & (d) (2)] & LAMP COMPATIBLITY [21 CFR 1040.20 (e) 2 (iii)]

Total Number of Lamps in Unit:__________________ Lamp Compatibility Information : YES / NO / N/A

Lamp Model Designation:__________________________________ Number of Lamps: ______ Manufacture:__________________________

Lamp Model Designation:__________________________________ Number of Lamps: ______ Manufacture:__________________________

Facilities Lamp Supplier(s) (name, address, fax & phone #):_________________________________________________________________

TIMER [21 CFR 1040.20 (C)(2)]

Type of Timer: Digital / Electro-mechanical / Spring Wound / Token / Other:________________________________

Timer Capabilities:_________(Minimum Time) _________(Maximum Time) Timer Interval (i.e. 1min increments): ___________________

Timer Interval Compatible with Exposure Schedule: YES / NO, If "NO", Explain:_______________________________________________

Timer Manufacturer Name and Address:_________________________________________________________________________________

Timer Accuracy: 10%: __________min __________sec, 50%: ____________min __________sec, 100%:___________min ___________sec

(Note: Record Timer Accuracy in minutes and seconds for 10%, 50% and 100% of Maximum Timer Capability for the Sunlamp Product. Remote timers are acceptable provided all other requirements of (C)(2)/(3) are maintained.)

TERMINATION CONTROL [21 CFR 1040.20 (C)(3)]

Presence: YES / NO Description: Toggle / Push Pull / Push Button / Other:_________________________________

How is exposure re-initiated:________________________________________________________________________

USER INSTRUCTIONS [21 CFR 1040.20 (e) (1)] (i.e. owner manual / operator manual)

Provided by the Manufacturer: YES /NO, Available to Patrons: YES / NO, Contains Instructions To Determine Exposure Schedule and Skin Types: YES / NO, Contains Reproduction of "WARNING LABEL" : YES / NO, Contains Instructions for Obtaining Replacement

Parts and Repairs: YES / NO, If "NO" to any, Explain:___________________________________________________________________

INSPECTIONAL CHECKLIST REPORT
FOR SUNLAMP PRODUCTS MANUFACTURED PRIOR TO SEPTEMBER 8, 1986
(Including Pertinent Parts of the Regulation)

Home District_________   CFN/FEI_________Product Type:________________________________________

Model_________Serial Number Date_________ Manufactured _________ / _________ / _________

Lamps: UV-A_____UV-B _____HID _____Properly labeled _____Mfr/Model:_______________________________________

Max Timer Setting _____Gradations_____Consistent w/exposure schedule:__________________________________

Timer Exceed Max. Recom. Exp._________Accuracy @ 10%___________  50%___________   100%___________

Type of Timer___________ (e.g. Token) Mfr. of Timer_______________How can user terminate exposure? ______________

How is exposure re-initiated? ____________________________________ Eyewear_________Sufficient #_________

Labeling visible w/eyewear ____ Eyewear Mfr. and Model_____________________________________________________

Certification Label: _______ (Va___________)Permanently affixed___________ Viewable_____________________

Location_____________________  Properly Worded____ Mfr. I.D. Label_______________________ Viewable_________

Full Name/Address_____________________  Date Mfrd.___________ Place Mfrd.________________

Warning Label: Readily Viewable_______ Location_____________________ Danger Statement ___________

Lamp Type___________ Min. exposure distance_______ How measured _____Warning: Min. exposure distance_________

Warning: Protective Eyewear _________ Warning: Max. exposure time_________ Exposure Schedule __________________

Time before results can be expected_______ Any misleading statements?__________________________________________

User's Instructions: Provided by the Mfr. ______ Available to patrons ____________________________________________

Contains copy of warning label_______ Instructions for replacement parts _______ Statement of # of people/eyewear _______

Equipment Recommendations: User position indicated _____ Timer error less than 10% ________  Temperature Control ________

Electrical Safety_________ Mechanical Safety_________ Protection from Lamps______   Access and Support ______

Attachment D: Specific Instructions for Cabinet X-Ray Product Inspections and Tests

Purpose

The Radiation Safety Performance Standard for Cabinet X ray Systems [Title 21 CFR § 1020.40] (performance standard) was designed to protect the public and system operators from unnecessary radiation hazards associated with the use of cabinet x-ray systems. The performance standard sets an exposure emission limit of 0.5 milliRoentgen (mR) in one hour for radiation emitted from a cabinet x ray system. Additional required safety features include interlocks, indicator lights, and warning labels. The performance standard applies to all cabinet x ray systems manufactured or assembled on or after April 10, 1975. Requirements regarding x ray systems designed primarily for the inspection of carry on airline baggage apply to systems manufactured or assembled on or after April 25, 1974.

Specific Instructions

The potential risk from a cabinet x-ray system is dependent on the maximum power that can be delivered to the x-ray tube and the environment in which the system is used. A cabinet x-ray system that can operate at higher peak tube potential and tube current will present a greater potential risk when compared with a lower power cabinet x-ray system. The following is an example of how the use environment affects the potential risk: a cabinet x-ray system used for checking circuit board quality is integrated into an automated production line and very rarely approached by anyone poses a lower potential risk than a carry on baggage security x-ray system which is loaded by members of the public and always has an operator present in close proximity.

Follow the general guidance on inspection, investigation, and field test priorities provided in section II.B.3 above and use your discretion based on the preceding discussion of potential risk. An example inspection checklist of cabinet x-ray specific issues has been included. For further guidance on compliance with specific requirements of the performance standard see the Cabinet X-Ray Compliance Guide (see reference below).

Radiological Health Specialists have been specifically trained in general EPRC requirements and also have specialized training in the cabinet x-ray product performance standards. These specialists should perform cabinet x-ray inspections and field tests, and may train additional field staff or accompany a medical device investigator to conduct joint EPRC/medical device inspections.

When conducting a cabinet x-ray system manufacturer inspection or field test all FDA personnel are required to wear a personal radiation monitor. If you do not have a personal radiation monitor badge, follow the instructions as noted in Part II of this program.

CDRH is responsible for all administrative/regulatory action, regulatory follow up, and for the issuance of all notices of violations to manufacturers of cabinet x-ray systems.

Field Test Instructions

Generally cabinet x-ray field tests should be performed when requested by CDRH, in response to requests from other federal agencies, to check the validity of a trade or consumer complaint, or when it is necessary for confirmation that a manufacturer’s testing program or corrective action plan is adequate.

When performing a cabinet x-ray field test collect data in accordance with the written procedures prescribed in “Routine Compliance Testing for Cabinet X ray Systems to which 21 CFR Subchapter J is applicable, Dated March 1985” (see reference below). If it is determined that the written procedures cannot be followed, describe in detail the variance from the prescribed procedure in the comments section of the test form.

Field Test Equipment: MDH meters are not sufficiently sensitive to detect radiation emissions from a cabinet x-ray system. Use only the meters identified in the field test procedure identified below.

NOTE: Cabinet X-Ray Systems installed at airports are not to be field tested except as requested by CDRH, Transportation Security Administration (TSA), Customs and Border Protection (CBP), or Department of Agriculture (USDA). Usually there will be a manager from the relevant agency at the facility containing the system to be tested. Coordinate the test with the appropriate agency on-site manager. Where the national radiation safety contacts are known they should also be contacted. The national contacts for TSA and CBP are included below:

Contacts for Radiation Safety at other Federal Agencies

Results for all field tests of TSA or CBP cabinet x-ray systems should be sent CDRH, the appropriate contact listed above, and the on-site manager.

References

Frequently Asked Questions on Cabinet X-ray Systems (March 24, 2003)
http://www.fda.gov/cdrh/radhealth/products/cabinetxrayfaq.html

Compliance Guide for Cabinet X-Ray Systems: Coming soon to the web

Routine Compliance Testing for Cabinet X-ray Systems to which 21 CFR Subchapter J is applicable, Dated March 1985
http://www.fda.gov/cdrh/radhlth/pdf/cabgdeft.pdf 

Refer to the Cabinet X-Ray Systems main page for additional information:
http://www.fda.gov/cdrh/radhealth/products/cabinetxray.html

Cabinet X-Ray Product Codes

Classification of Non-compliant Items

Cabinet X-Ray Product Inspection Guidance and Field Test Form

Cabinet X-ray inspection checklist.

This guidance is in addition to the instruction provided in Part III.A.2 of this program. Refer to the Compliance Guide for Cabinet X-Ray Systems (referenced above) for a detailed discussion of the cabinet x-ray system performance standard.

1. Record Firm Identification, Location, and Contact information
2. Models
   1. What models does the manufacturer produce?
   2. What models are available for observation of certification testing?
3. Performance Requirements
   1. Radiation Emission Limit
      Unlike lasers, the “characterization” of the radiation emitted from a cabinet x-ray system is not relevant. The amount of x radiation emitted is critical. Note: The emission limit in the cabinet x-ray standard is for the amount of exposure (less than 0.5 mR) in one hour. It is not a limit on the instantaneous rate of radiation emission.
      1. Is there a written procedure for emission testing?
      2. Are numerical values recorded for the worst case emission from each system?
      3. What instruments are used during emission testing? (Record the model and manufacturer of each radiation meter)
         1. Identify the type of each meter (ideally the mfr. should know the type). A few possible types are: ion chamber, Geiger-Mueller (GM), plastic scintillators.
         2. What is the response time for each meter?
         3. Can the x-ray system produce a beam for longer than the meter’s response time? Does the procedure specify that x-ray will be produced for longer than the meter’s response time?
         4. Is the meter held still at various positions around the x-ray system or is it moved slowly around the system?
            1. If the meter is in motion during an exposure is there a maximum scan speed noted in the procedure?
            2. During the test, is the meter moved slowly enough so that its response time is not a factor?
            3. Is the scan speed limit adhered to by the person performing the test?
            4. Are all the likely points of excess emission checked? If there are emission issues they usually occur at the ports, seems, corners, access panels, and doors.
         5. If the x-ray beam can not be produced continuously can the radiation meter measure an integrated dose?
         6. Does the meter used for the quantitative measurement have a current calibration? What energy was the meter calibrated at? What is the peak tube potential of the cabinet x-ray system?
         7. Does the meter produce a linear response for the expected energy range of emission from the product?
         8. Is the meter sufficiently sensitive in the relevant energy range that it responds to radiation emission from the product?
      4. If there are calculations involved in determining the total amount of exposure in anyone hour are all the steps clearly identified and justified?
      5. What is the rejection limit set by the manufacturer for emissions? If the rejection limit is the same as the limit in the performance standard how is the inherent experimental error in measuring radiation emission from the system accounted for? If less than the limit in the performance standard is it sufficiently restrictive to account for experimental error?
      6. Based on the answers above and observation of the emission test procedure, is the emission testing conducted by the manufacturer sufficient to assure that the product will comply with the performance standard?
   2. Are items placed into the cabinet through a port or through a door?
      1. If items are placed into the cabinet through a port is it necessary for someone to hold the item while it is being exposed to radiation? If so can any part of the body reach the primary beam through the port?
      2. If items are moved into the system on a conveyor belt will any part of the body reach the primary beam during normal operation? (Crawling into the system is not considered normal operations)
      3. If it appears that it is possible to reach the primary beam inadvertently ask the manufacturer for the exposure rate in the primary beam per hour.
   3. If the system has a door does it have a minimum of two interlocks? Note: A door is used to put a sample into the cabinet. If a part of the shielding is opened for maintenance it is an access panel not a door.
      1. Is at least one of the interlocks designed so that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator? Occasionally a system may have a “shutter” so that when either the shutter or the door is closed energy continues to be supplied to the high-voltage generator and if both were to open simultaneously then the power would be cut.
      2. Is the disconnection dependent upon any moving part other than the door? In most cases the secondary physical disconnect interlock will be visible when the door is open. Relays and magnetic switches contain moving parts and do not meet this requirement.
      3. Will closing the door cause the automatic resumption of x-ray production or is it necessary for an operator to re-initiate x-ray production by taking some action?
   4. Does the system have an access panel?
      1. Do all access panels that allow access to the interior of the cabinet require a tool to open?
      2. Do all access panels have an interlock that prevents production of x-ray when the panel is open?
      3. Will closing an access panel cause the automatic resumption of x-ray production or is it necessary for an operator to re-initiate x-ray production by taking some action?
   5. Has the manufacturer performed a ground fault analysis? Can the product fail via a ground fault in such a way that x-ray production is initiated?
   6. Is there a capture key control? Can the key be removed when in a position that allows the production of x-ray?
   7. Is there a control to initiate and stop x-ray production other than the power key?
   8. Are there at least 2 independent means that indicate when and only when x-ray is being produced? Are they labeled “x-ray on”?
   9. Can an x-ray on indicator be seen from any position that a port, access panel, or door can be operated? Is the indicator labeled “x-ray on”?
   10. Is the system designed to admit humans? Is the system so large that it would be easy for a human to walk into the cabinet?
       1. Is there a control inside the cabinet for terminating x-ray generation?
       2. Can x-ray generation be initiated from within the cabinet?
       3. Are there audible and visible warning signals within the cabinet that are actuated for at least 10 seconds prior to the first x-ray generation after closing any door designed to admit humans?
       4. Visible warning signal within the cabinet that is illuminated when and only when x-rays are being generated?
       5. Signs that indicate the meaning of the warning signals provided to meet the other requirements of this section?
   11. Warning labels
       1. At the location of any controls that can be used to initiate x-rays is there a label that says: Caution: X-Rays Produced When Energized
       2. Is there a label at every port that says: Caution: Do Not Insert Any Part of the Body When System is Energized--X-ray Hazard
   12. Are user instructions provided to purchasers?
       1. Do the instructions include: Potential, current, and duty cycle ratings of the x-ray generation equipment; and adequate instructions concerning any radiological safety procedures and precautions which may be necessary because of unique features of the system?
       2. Do the instructions include a schedule of maintenance necessary to keep the system in compliance with this section?
   13. Does the product require the customer or a third party to be assembled? If so are there adequate assembly instructions provided by the manufacturer?
   14. Is the product used for security screening of items placed on it by members of the public?
       1. Are there means provided to assure that the operator is present at the control area and in a position that permits surveillance of the ports and doors during generation of x-radiation?
       2. Are there means provided to assure that the operator can terminate an exposure?
   15. Is the manufacturer modifying a previously certified system? If so have they re-labeled the system and re-identified and recertified that the modified product meets the requirements of the performance standard?

Field Test Form

The cabinet x-ray field test procedure uses an official form to record the data. This form, FDA 2903 entitled, Cabinet X-Ray Systems Field Test Record can be found at the FDA Forms Catalog (see the FDA intranet home page under Medical Devices).

Attachment E: Specific Instructions for Television Product Inspections

Background

The Television Product Performance Standard (the standard) was designed to protect the public from x-radiation hazards associated with early cathode-ray-tube (CRT) television sets. The radiation emitted from these products has been dramatically reduced over the years as a result of the standard, and by improvements in technology and design. The hazards of x-ray emissions from CRT televisions and video monitors are further diminished because of a well-established and conscientious industry and the increasing market for flat panel LCD and plasma displays that do not pose a radiation hazard. A minimal, but risk-based and continued presence by FDA is needed in the television industry to ensure continued compliance with radiation safety standards so long as there is a market for CRT products. This presence is limited to for-cause manufacturer inspection and laboratory inspection. No field tests are conducted on television products.

Specific Instructions

Television product manufacturers should be inspected or tested at CDRH direction. Television product manufacturers are all located overseas, and all inspections will require foreign travel. Reasons for manufacturer inspection include:

• Manufacturers with known or suspected problems based on previous inspection or complaints
• New manufacturers not yet inspected
• Manufacturers introducing new CRT-based technology to the US market
• Manufacturers with a large potion of the US market share.

WEAC laboratory analysts have knowledge of general EPRC requirements and also have specialized training in the television product performance standard. These analysts have experience planning and conducting foreign television manufacturer inspections. WEAC analysts should perform these inspections and field tests and may train additional field staff.

CDRH is responsible for review of television manufacturer inspection observations and initiating administrative or regulatory follow-up.

References

Performance Standard-Television Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.10

Reporting and Compliance Guide for Television Products
http://www.fda.gov/cdrh/radhlth/pdf/tvvrptgd.pdf

Refer to the television products main page for guidance documents and additional information:
http://www.fda.gov/cdrh/radhealth/products/tvvdt.html

Television Product Codes

Classification of Non-compliant Items

Sample Television Product Inspection Checklist

Manufacturer Identification

FDA Personnel

LIST OF EXHIBITS

GENERAL EVALUATION OF THE SPECIFIC AREAS INSPECTED

*Legend for Evaluation: A - Satisfactory B - Questionable C - Unsatisfactory

NARRATIVE DESCRIPTION OF FINDINGS

1. PRODUCTION SUMMARY

MAXIMUM NUMBER OF PRODUCTION LINES =

2. GENERAL ORGANIZATION

3. ENGINEERING

4. INCOMING TESTS FOR CRITICAL COMPONENTS

1. Test Summary

11. X-RADIATION TEST RECORDS

4. What information is recorded?

5. Are any records in excess of the rejection limit?

1. Test Instrumentation

a) Identification of receiver tested:

b) Labeling Information:

c) Test Conditions:

d) Test Results:

a) Identification of receiver tested:

b) Labeling Information:

c) Test Conditions:

d) Test Results:

Attachment F: Specific Instructions for Microwave Oven Product Inspections

Background

The Microwave Oven Product Performance Standard (the standard) was designed to protect the public from unnecessary emissions from microwave ovens. A minimal, but risk-based and continued presence by FDA is needed in the microwave oven industry to ensure continued compliance with radiation safety standards. This presence is limited to for-cause manufacturer inspection and laboratory inspection. No field tests are conducted on microwave oven products.

Specific Instructions

Microwave oven product manufacturers should be inspected or tested at CDRH direction. Microwave oven product manufacturers are all located overseas, and all inspections will require foreign travel. Reasons for manufacturer inspection include:

• Manufacturers with known or suspected problems based on previous inspection or complaints
• New manufacturers not yet inspected
• Manufacturers introducing new technology to the US market
• Manufacturers with a large portion of the US market share.

WEAC laboratory analysts have knowledge of general EPRC requirements and also have specialized training in the microwave oven product performance standard. These analysts have experience planning and conducting foreign microwave oven manufacturer inspections. WEAC analysts should perform these inspections and field tests and may train additional field staff.

CDRH is responsible for review of microwave oven manufacturer inspection observations and initiating administrative or regulatory follow-up.

References

Performance Standard-Microwave Oven Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1030&showFR=1

Guide for Preparing Reports on Radiation Safety of Microwave Ovens
http://www.fda.gov/cdrh/radhlth/pdf/mworptgd.pdf

Refer to the microwave oven products main page for guidance documents and additional information:
http://www.fda.gov/cdrh/radhealth/products/microwave.html

Microwave Oven Product Codes

Classification of Non-compliant Items

Sample Microwave Oven Product Inspection Checklist

Manufacturer Identification

F.D.A. Personnel

Manufacturer Personnel

LIST OF EXHIBITS

GENERAL INSPECTION OVERVIEW

SUMMARY OF FINDINGS (See the FDA483 in Exhibit A)

HISTORY OF BUSINESS

PERSONS INTERVIEWED AND INDIVIDUAL RESPONSIBILITY

FIRM'S TRAINING PROGRAM

RAW MATERIALS AND COMPONENTS

MANUFACTURING PROCEDURES

SAMPLES COLLECTED

Y2K ISSUES

COMPLAINTS

REFUSALS

DISCUSSION WITH MANAGEMENT

1.0 Production Summary Maximum number of production lines is:

* CTD = Countertop/Domestic CTC = Countertop/Commercial UTC = Under‑the‑cabinet WHO = Wall hanging COM = Common cavity MOD = Module for High/Low HLO = High/Lo BDO = Built‑in‑double BSO = Built‑in single

2.0 Component Inspection

*Test Parameter Keys: D = dimension check, E = electrical continuity or performance, F = function check, RF = RF emission check, V = visual inspection, W = weld integrity

3.0 Component Control

3.1 Are the incoming components adequately controlled to prevent their use until quality control tests are completed and lot acceptability is determined?
Yes ____ No (Explain) ____________________________

3.2 Are the rejected lots of components adequately marked or secured so the rejected parts are not used in production unless reworked?
Yes ____ No (Explain) ____________________________

4.0 Production Line and Final Tests

4.1 Are the written procedures or diagrams available or posted in the working area for the operator performing Q.C. checks?
Yes ____ No (Explain) ____________________________

4.2 Are repaired ovens returned to the assembly line at a point prior to the test that caused their rejection?
Yes ____ No (Explain) ____________________________

4.3 Are all repaired ovens, regardless of the nature of the repair, returned to the assembly line for the open door operation test and final RF emission test?
Yes ____ No (Explain) ____________________________

6.0 Automated Microwave Oven Scanner

* User manual provided to person responsible for operation of AMOS?
____ Yes _____ No

* Maintenance record shows regular and adequate maintenance of the AMOS (cone checks, wires, RF absorbers, etc.)?
____ Yes _____ No

7.0 Microwave Emission Final Test

general instrumentation :**warm up, **reset zero, **dirty cones, **AC cover missing, **battery check, **voltage supply for AC powered meters, **barrel holding

8.0 Quality Audit