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Office of Device Evaluation Annual Report Fiscal Year 2006 and Fiscal Year 2007
(Part 4 - Major Program Initiatives)

PANDEMIC AND AVIAN INFLUENZA

I had a little bird
Its name was Enza
I opened the window
And in-flu-Enza*  

(*A rhyme recited by children while jumping rope during the 1918 influenza pandemic. It can be found at: “The 1918 Influenza Pandemic” @http://virus.standford.edu/)

As the density of the world population increases, we are ever faced with diseases of global proportion. In 1918-1919, the world experienced an influenza pandemic which killed 20-40 million peopleworldwide. Todaymost experts believe that we are on the brink of another pandemic of global impact. The possible source of a pandemic may be avian influenza caused by the highly pathogenic H5N1 (HPH5N1) virus. To that end there has been much activity going on at the Department of Health and Human Services (DHHS) to develop strategies that can be implemented if such a scourge happens again. DAGID staff have been actively sought after to participate on committees working on influenza and pandemic issues, and to review numerous documents on emergency preparedness and pandemic issues. The meetings are both within the Department of Health and Human Services involving severalagencies such as the FDA and the Centers for Disease Control and Prevention; and, inter-departmental including the Department of Homeland Security and Department of Labor. The documents reviewed come from The White House, Department of Labor, Department of Homeland Security, Department of Agriculture, the Environmental Protection Agency, Department of Education, Institute of Medicine and many others.

Many of the medical devices reviewed by DAGID staff play an integral role in both the minimization of exposure to infectious agents and the delivery of treatment modalities for those who are ill. These include personal protective equipment such as surgical gowns, surgical masks and surgical N95 respirators, gloves, sterilants and high level disinfectants, ventilators, oxygen concentrators, and even needles, syringes and intravascular equipment which will be needed in great quantities during either a natural or man-made disaster.

PROGRAM FOR ASSESSING THE QUALITY OF PREMARKET REVIEW MEMOS

In FY 06 and FY 07, the Office of Device Evaluation continued, and expanded, its program to assess the quality of the documentation within review memos for premarket submissions. The program began in FY 05 with two scientific elements common to many premarket submissions - biocompatibility and sterility/packaging. Since then, two additional review areas have been added – software (FY 06) and clinical (FY 07). Teams consisting of subject matter experts in each scientific area were assembled from across CDRH Offices. Each team created a set of “critical review elements” which were deemed essential for documentation or inclusion in a review related to that area. These elements were used to assess the quality of review memos from randomly selected 510(k)s (or IDEs for the clinical team) and PMA submissions with recent final decisions. Teams were scheduled to participate in two assessment rounds per year.

- Sterility Assessments

We have completed three rounds of assessments of quality issues in terms of documentation of sterility review. Some quality review issues were noted. In response, division focal points were identified to provide assistance to reviewers in the divisions. In addition, ODE staff conducted a Staff College course (December 2006) and created a review checklist (April 2007) to educate and assist reviewers in performing sterility reviews. A fourth round of assessment, following implementation of these interventions, showed a marked improvement in the quality of review memos.

The Office will continue to assess the results of sterility reviews over the coming year to measure the impact of our interventions.

- Biocompatibility Assessments

A total of 4 rounds of biocompatibility document review have been completed through 2007. Some quality review issues were noted.

In response, a biocompatibility review checklist was developed by the assessment team and will be introduced to the ODE review divisions in 2008. A Staff College course for performing biocompatibility reviews will be offered in 2008 as well. The Office will assess the impact of these interventions in future assessment rounds once they are implemented.

- Software Assessments

Three assessment rounds have been completed for software reviews through 2007. Some quality review issues were also noted.

The software assessment team identified focal points for each of the review divisions and in 2008 will be creating a reviewer template for completing software review. A training course for basic software review will also be developed for pre-market reviewers to improve the quality of the review documentation.

- Clinical Assessments

Through 2007 the clinical team (the newest team) has completed an initial assessments of IDE clinical review memos. The Office will continue to assess the results of software reviews over the coming year.

The clinical team will continue to gather data on IDE and PMA review memos during the coming year.

TRANSFER OF POST-APPROVAL STUDY RESPONSIBILITIES

FY 06 and FY 07 saw the creation and implementation of a Memorandum of Understanding for the transfer of post-approval study (PAS) responsibilities from ODE to the Office of Surveillance and Biometrics (OSB). During this time, epidemiologists from OSB have been consistently consulted for original and panel-track PMA submissions received by ODE. The epidemiologists are now included as integral parts of the PMA review team at the early stages, focusing their efforts on interacting with ODE staff and device sponsors in determining appropriate post-market clinical study questions and developing the PAS to adequately address these issues. As part of this initiative, epidemiologists from OSB have participated in several Advisory Panel meetings as part of the FDA team, making presentations regarding the proposed PAS for the application under consideration. They have also been providing updates to Panels with regards to the status of on-going PAS. In addition, during this time OSB has assumed responsibility from ODE for reviewing and responding to PMA reports for PAS.

During FY 06 and FY 07, with the assistance of ODE staff, OSB populated its new electronic database (COATS – Conditions of Approval Tracking System) to track the status of all PAS ordered as a Condition of Approval. This database, which is now fully operational, allows CDRH to notify sponsors if and when PAS reports are due or overdue. Certain data from this tracking system are also now made available to the public on CDRH’s website.

ODE COLLABORATIVE REVIEWER PROGRAM

In 2007, ODE, in conjunction with the Office of Surveillance and Biometrics, launched the ODE-OSB Collaborative Reviewer Program as part of CDRH’s Postmarket Transformation initiative. The pilot program, which began in March, was intended to facilitate and encourage communication between pre- and post-market programs.

Twenty-three (23) reviewers from ODE were selected and trained to participate in the program. In addition to their regular pre-market review duties, these reviewers are spending approximately half of their time performing traditional post-market surveillance activities including review and analyses of Medical Device Reports (MDRs). It isanticipated that having staff simultaneously performing pre- and post-market activities for a particular set of medical device products will benefit the Center in several ways. These include earlier detection of post-market signals, using real-world post-market information as feedback to improve pre-market review of similar or later generation products, as well as bringing a unique perspective to the interpretation and evaluation of post-market events based on familiarity with the premarket history of the device or device type. This program will continue throughout 2008.

LEVERAGING IT SYSTEMS FOR INCREASED EFFICIENCY

ODE continued to pursue development of new IT systems for improved tracking and monitoring of submissions. We review our current systems and consider the infrastructure needs required to move toward electronic submissions.

- Electronic Copies

In FY 06, ODE received 262 complete electronic copies of submissions for original PMAs, IDEs, and 510(k)s in addition to the paper submission. These numbers show an increase from FY 04 when 74 electronic copies were received. In FY 07, the number of complete electronic copies of submissions continues to increase to almost 800.

ODE encourages all manufacturers to submit electronic copies along with the paper submission whenever possible. Electronic copies will save resources for the FDA and will provide additional navigational tools for the review staff who will be working with the document. In addition, the electronic copy may serve as one of the required paper copies. Instructions for submitting submissions in electronic form can be found on the CDRH home page at the address http://www.fda.gov/cdrh/elecsub.html.

- Information Systems For Document Tracking And Archiving

Numerous enhancements were made to information systems used by ODE during FY 06. The acknowledgement letters for all application types were modified to include electronic copy information. The CDRH electronic copy initiative encourages all manufacturers to submit electronic copies along with the paper submission whenever possible. The PMA data entry program was modified to capture the new annual report calculation, and the premarket letters were changed to work on the new printers. The premarket databases were updated due to the ODE/DGRND reorganization, and the premarket data was reviewed in support of the design and development of the premarket data warehouse.

In FY 07, the CDRH Ad hoc Reporting System (CARS), which provides a data warehouse and business intelligence portal for extensive reporting and analysis of CDRH data, had two major releases. The first release of CARS contained primarily 510(k) data. The second release was in support of MDUFMA and provided MDUFMA reports for 510(k), PMA, and Modular PMA submissions as well as supporting ad hoc queries of 510(k), PMA, Modular PMA, and 513g data.

The Center Tracking System (CTS) was modified to include an Interactive Review Log feature in support of MDUFMA and to include additional enhancements to display MDUFMA due dates. The combination product flag was added to CTS to allow reviewers to set the value for that field and changes were made to the PMA and 513g data entry programs in support of MDUFMA. The premarket applications were also modified in order for those applications to link to FURLS (FDA Unified Registration and Listing System).

- Improved Communication and Interaction Tools For PMA Review Teams

ODE continued to use eRoom to facilitate communication and interactions among team members in the review of PMAs. In FY 07, we continued to create eRooms to store documentation related to the review of individual ODE and OIVD original PMAs and panel-track supplements. PMA team members are using the eRoom template to organize and save letters, review memos, meeting documentation, and email throughout the PMA review.

In addition, ODE created a general PMA eRoom that is used by CDRH as a primary source of documents related to PMAs. The PMA eRoom includes boilerplate letters for ODE, OIVD, OC, and OSB. It also includes key staff memos and emails, spreadsheets, links to guidances, internal procedures, etc.

Both the eRooms for each individual PMAs and the general PMA eRoom have improved the efficiency and consistency of PMA reviews.

As a result of the success with the PMA eRoom, this same concept was applied to all the premarket programs and was expanded to include 510(k), IDE, and HDE programs.

- Hardware Upgrades

ODE purchased replacement laptop computers for the remaining staff on board in FY 06 and for some new employees who arrived in FY 07. ODE continued to upgrade its equipment infrastructure with the purchase of facsimile machines, replacement printers for secretaries, consumer safety technicians and the document control center employees, shared color laser printers, scanners for travel preparers, and LCD projectors for meetings. There were no significant computer hardware upgrades in FY 07.

THE DEFIBRILLATION WORKING GROUP (DWG)

The Defibrillation Working Group (DWG) has been an important focus of DCD and Center activities. The group is composed of representatives from each of the Offices within CDRH, primarily representing front-line staff and some managers. A Steering Committee comprised of senior managers within the Center provides oversight to the working group.

The DWG has created several mechanisms to improve internal communication among Center experts dealing with implanted pacemakers and defibrillators. Members of the group have tackled issues such as improving the content of PMA Annual Reports, developing a guidance document for Dear Doctor letters, and improving how we communicate with external stakeholders like the media and Congress. Some efforts, such as the creation of a Postmarket Advisory Panel, can be considered near completion, while others, such as the MedSun Heart Network, are part of a larger Center effort for which the DWG is providing necessary expertise.

COMBINATION PRODUCTS

Combination products, consisting of devices and drugs or devices and biologics, continued to be a focus of effort for ODE. In FY 06, we interacted with the FDA Office of Combination Products, the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) on the review of many combination device-drug and device-biologic products.

In FY 06, ODE reviewed 28 Requests for Designation (RFDs), 19 for device-drug combinations, 5 for device-biologic combinations, 1 for a drug-device-biologic combination, and 3 RFDs were determined to be non-combination device products. CDRH was given the lead for 18 of these. We also reviewed and acted on premarket applications for 139 new combination products. Our device expertise was called upon frequently by our sister centers and we performed 95 consulting reviews.

In FY 07, ODE reviewed 31 RFDs, 26 for device-drug combinations, 3 for device-biologic combinations, and 2 for drug-device-biologic combination. In FY 07, we reviewed and acted on premarket applications for 148 new combination products. Our device expertise was called upon frequently by our sister centers and we performed 120 consulting reviews.

Our staff is involved in many intercenter collaborative working groups, including:

Autoinjector Working Group
Cardiovascular Products Working Group
Cartilage Repair Group
CBER/CDRH Tissue Engineering Steering Committee
DHHS Joint Working Group on Telemedicine
FDA RFID Team
Interagency Blood Glucose Closed Loop Working Group
Interagency CWD Decontamination Working Group
Interagency Oncology Task Force Y
Multi-Agency Tissue Engineering Science (MATES) Interagency Working Group (IWG)
Orthopedic Indications Working Group
Tissue Engineering Working Group (FDA, NIH, NIST, NASA, DOE) 
Tissue Policy Team
Tissue Reference Group
Wound Healing Clinical Focus Working Group
Wound Care Solutions Working Group

ODE Device Guidance Documents

In FY 06, ODE issued 15 guidance documents, 8 Level 1 and 7 Level 2, which are listed below. Among the 15, 7 are Special Controls guidance. In addition to consulting with all of the offices across the Center on many issues addressed in guidance, one of the 13 was developed in collaboration with Office of Science and Engineering Laboratories (OSEL). These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/cdrh) which provides easy access to the latest information and operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041; fax 240-276-3103; Email dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.

ODE Device Guidance Documents

In FY 07, ODE issued 12 guidance documents, 9 Level 1 and 3 Level 2, which are listed below. Among the 12, 6 are Special Controls guidance. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/cdrh) which provides easy access to the latest information and operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041; fax 240-276-3103; Email dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.)

Reclassification Petitions

Any interested person may submit a petition to the agency for reclassification of a device, e.g., from class III to class II, or class II to class I. Additionally, the agency on its own initiative, may follow procedures to reclassify a generic type of device. There are five sections under the Federal Food, Drug, and Cosmetic Act by which we may reclassify a device, Section 513(e), 513(f) 514(b), 515(b) and 520(l) depending on the status of the device type, such as new device types found to be not substantially equivalent or transitional devices formerly regulated as drugs. The reclassification petition needs to contain sufficient information to allow FDA to determine that the proposed classification can provide reasonable assurance of safety and effectiveness. Reclassification petitions and their final decisions are put on public display at the Dockets Management Branch.

Proposed Reclassification Actions – FY 06 and FY 07

Published a proposed rule in the Federal Register on February 15, 2006, to reclassify bone sonometer devices from class III (premarket approval) into class II (special controls).

Published a proposed rule in the Federal Register on February 9, 2006, to reclassify intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III (premarket approval).

Published a proposed rule in the Federal Register on April 6, 2006, to reclassify topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls).

Published a proposed rule in the Federal Register on October 31, 2006, to reclassify the Absorbable Body Fusion Device form class III (premarket approval) into class II (special controls).

Published a proposed rule in the Federal Register on July 3, 2007, to reclassify the Tissue Adhesive for Topical Approximation of Skin Device from class III (premarket approval) into class II (special controls).

Final Reclassification Petition – FY 07

Published a final rule in the Federal Register on June 12, 2007, reclassifying the Intervertebral Body Fusion Device from class III (premarket approval) into class II (special controls).

Denial of a Reclassification Petition – FY 06 and FY 07

Published a denial in the Federal Register on July 14, 2006, regarding a request of change in classification of the breathing frequency monitor and the electroencephalograph from class II (special controls) to class I (general controls).

Published a notice of denial in the Federal Register on July 3, 2007, for a change in classification of the Impedance Plethysmograph from class II (special controls) to class I (general controls).

Published a notice of denial in the Federal Register on July 3, 2007, for a change in the classification of the Cutaneous Electrode from class II (special controls) to class I (general controls).

Advisory Panel Activities

The Center’s Medical Devices Advisory Committee (MDAC) consists of 18 panels, 13 in ODE and 5 in OIVD, that provide clinical and scientific advice to FDA in a wide range of medical specialties that are fundamental to the regulation of medical devices. The primary work of these panels involves: (1) review and recommendations on premarket submissions, primarily Premarket Approval Applications (PMAs), and 510(k)s, (2) classification and reclassification of medical devices based on risk to patients, (3) advice on guidance documents that provide industry and FDA staff with expectations for studies and data for premarket reviews, and (4) input on new issues or questions concerning the determination of the safety and effectiveness of medical devices.

In FY 06, 9 MDAC panel meetings were held. These panels reviewed and made recommendations on 6 PMAs, 10 preamendment device classifications, 1 Over-the-Counter (OTC) designation and 2 general issues. The MDAC panels reviewed PMAs for significant device breakthrough technologies such as a first of a kind cervical disk replacement which was also the first metal-on-metal articulation in the spine.

In FY 06, there were 8 training sessions for new MDAC panel members and consultants. At 3 of the MDAC meetings there were briefings on the new postmarket study design and follow-up procedures introduced on January 1, 2005, and at 3 ODE meetings the Agency’s Critical Path Initiative was outlined.

In FY 07, 14 Medical Device Advisory Panel meetings were convened for a total of 17 days. These panels reviewed and made recommendations on 11 PMAs, 1 premarket notification [510(k)], and 5 general issues. The panels reviewed PMAs for significant device breakthrough technologies such as a first of a kind non-constrained, mobile-bearing ankle prosthesis and a novel cervical disk prosthesis for patients with degenerative disk disease. The Circulatory System Devices Panel was convened to seek expert advice regarding postmarket safety issues with drug-eluting stents. Seven training sessions for new panel members were held in FY 07.

Two Medical Device Dispute Resolution Panel meetings were held in response to sponsor requests in December 2006 and April 2007. The Dispute Resolution Panel reviews scientific disputes between FDA and the sponsor. The panel provides a recommendation to the Center Director.

As part of the Center’s Postmarket Transformation, epidemiologists from the Office of Surveillance and Biometrics (OSB) participated in the review and the FDA presentation addressing the proposed post approval study plans submitted by device sponsors at 7 of the PMA meetings during FY 07. Additionally, updates of two post approval studies in progress were presented to the Advisory panel by both OSB and the device sponsors.

CDRH continuously recruits and selects highly qualified experts to serve as members and consultants on these panels. Potential candidates are asked to provide detailed information concerning financial holdings and employment as well as research grants and contracts to identify any potential or imputed conflicts of interest. Individuals interested in becoming panel members should send their curriculum vitae to www.fda.gov/oc/advisory/vacancies/acvacmain.html.

The MDAC panels ensure that the agency has access to the nation’s outstanding medical and scientific experts and make the FDA medical device review process transparent to all stakeholders. CDRH greatly appreciates the many contributions that the advisory panel members and consultants make to the challenging tasks of the medical device review process.

The following 6 ODE panels of the Medical Devices Advisory Committee met during FY 06:

Dental Products
General and Plastic Surgery
Obstetrics and Gynecology
Ophthalmic
Orthopaedic and Rehabilitation
Radiological

The following 7 ODE panels of the Medical Devices Advisory Committee met during FY 07:

Dental Products
Immunology
Circulatory Systems
Dispute Resolution
Neurology
Orthopaedic and Rehabilitation
General Hospital

Transcripts from the Medical Devices Advisory Committee meetings can be found at:
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

ODE/OIVD Application Integrity Program

Under the Application Integrity Program, ODE/OIVD considered many cases concerning the integrity of data submitted to the agency in premarket submissions. During FY 06, we managed 50 potential or actual cases and during FY 07 we had 54 such cases.

During 07, we issued two Integrity Hold (IH) letters.

FDA removed IH restrictions from two firms during FY 06. During FY 07 we removed IH from three medical device manufacturers and similar restrictions from another firm that was not officially on IH.

In managing this program, we reviewed many major documents including inspectional findings, data audits, system audits, and corrective action plans for cases in process.

Our staff also worked with the Office of Criminal Investigation (OCI) on various data integrity cases and issues.

Updated June 19, 2008

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