Dear Medical Device Manufacturer:

January 21, 1998

Dear Biomedical Equipment Manufacturer:

The Year 2000 date compliance issue holds serious implications both for the patient care and scientific research activities of the Federal government, and for the nation's health care providers and researchers in general. Because it is imperative that biomedical equipment continues to function properly in the next century, the Department of Health and Human Services (HHS) is requesting information about the Year 2000 compliance of medical devices and scientific laboratory equipment manufactured by your company.

Medical devices and scientific laboratory equipment may experience problems beginning January 1, 2000 if the computer systems, software applications, or embedded chips used in these devices and equipment contain two-digit fields for year representation. Agencies, such as the Department of Defense, Department of Veterans Affairs, and Department of Agriculture as well as HHS, are concerned that the existence of the Year 2000 date problem in biomedical equipment could pose potentially serious health and safety consequences.

On behalf of the Department, I strongly urge you to identify products, which are not Year 2000 compliant, and to detail how and when these products will become compliant. If all your products are compliant, you may provide a statement certifying total compliance of products.

The enclosure provides the address of the web site to which you may link your own web site containing compliance information about your product lines. If you prefer, you may mail noncompliant product information or the total compliance statement to HHS. The mailing address is also listed in the enclosure. All information received will be made available to the public through the government web site, and the public will have full access to the list of manufacturers who respond. In addition, there will be targeted follow-up regarding non-respondents, and cooperation at the onset will save both time and taxpayer dollars.

I know you share our commitment to the uninterrupted provision of our nation's vital patient care services and health research initiatives in the new millennium. Thank you for your cooperation.

Sincerely,

Kevin Thurm

Enclosure

Enclosure to January 21, 1998 Letter to Manufacturers

Medical Device and Scientific Laboratory Equipment
Year 2000 Compliance Information

The Federal Government has established a World Wide Web site to provide information regarding the Year 2000 compliance of medical devices and scientific laboratory equipment. The general public, including government agencies that purchase and use biomedical equipment, and the health care and research communities will have access to this web site. Manufacturers of biomedical equipment are urged to provide the information described below regarding the Year 2000 compliance status of their products, including both current and previously manufactured products.

For the purpose of this product status reporting, Year 2000 compliant means, with respect to medical devices and scientific laboratory equipment, that the product accurately processes and stores date/time data (including, but not limited to calculating, comparing, displaying, recording and sequencing operations involving date/time data) during, from, into and between the twentieth and twenty-first centuries, and the years 1999 and 2000, including correct processing of leap year data.

The above definition is a slight modification of the definition of "Year 2000 Compliance" as used in the Federal Acquisition Regulations for information technology products to address medical devices and scientific laboratory equipment (see 48 CFR Part 39.002). The intent is that for products to be Year 2000 compliant they must function as intended or expected, regardless of the date. A manufacturer's reporting of Year 2000 compliance status should include all products (units) produced which could still be in service.

Manufacturers are requested to provide one of the following two items of information.

A certification that all of the manufacturer's products are Year 2000 compliant or a certification that the date problem is not applicable to any of their products. (This certification can only be made if the manufacturer has assessed the compliance status of all products. Otherwise, a status of AI (see below) with date must be reported for those products not yet assessed.)
A listing of products which have Year 2000 compliance problems (are not compliant under the definition given above) with sufficient information to identify the specific product (as described below).
- Type of product ( Generic description of product. For medical devices, the generic type of device as used in the device classification regulations of 21 CFR Parts 860 - 892 may be an appropriate description.)
- Owner/Operator Number if manufacturer is an FDA regulated firm
- Original manufacturer (if different from company providing information)
- Model number
- Specific serial numbers (if appropriate)
- Software version number
- Brief description of the date-related problem
- Solutions to be offered by manufacturer to mitigate problem - one of the following codes should be used to indicate solution to be provided for the product
  - SU/date - Upgrade to software will be available by (date) at no cost to purchaser.
  - SU-C/date - Upgrade to software will be made available by (date) at a cost to purchaser.
  - HU/date - Upgrade to product (hardware and software) will be made available by (date) at no cost.
  - HU-C/date - Upgrade to product (hardware and software) will be made available by (date) at a cost.
  - M - Minor date-related problem with product, presenting no adverse health impact on product function and for which manufacturer will not provide a correction/upgrade.
  - O - Product is obsolete or beyond reasonable useful service life and no upgrade will be provided.
  - AI/date - Assessment of compliance status is currently incomplete but is underway and information will be made available by (date).
- Point of contact to discuss product information (including name, address, telephone number, fax number, and e-mail address)

The information may be provided using one of the following methods.

Posting the noncompliant product information or the certification of total product compliance on a manufacturer operated web site and providing the URL for the web site to the FDA at either of the addresses given below. The FDA will incorporate a link to the manufacturer's web site from the government maintained site providing the product Year 2000 compliance data. A condition imposed by the government on providing this link is that the link be directed to a portion of the manufacturer's web site which directly provides the full data elements or certification described above and not to a page providing other types of information or product promotion.

Submitting information directly to FDA electronically by completing the data entry form provided on the government web site at http://www.fda.gov/cdrh/yr2000/ y2kform.html using the USER ID = and the PASSWORD = (ID and password contained in letter sent to manufacturers only).
Mailing the noncompliant information or certification of total product compliance to the address listed below, for posting by the government on the government web site.

Mailing address: Food and Drug Administration
Attn: Y2K Medical Devices Coordinator
Center for Devices and Radiological Health
Mail Code HFZ-Y2K
9200 Corporate Boulevard
Rockville, MD 20850

In order to best serve the industry, as well as recognizing the limited time available before the Year 2000, we ask all manufacturers to respond within sixty days. The provision of information, by either of the methods described above for posting on the government web site, signifies that the information provided is true and complete and covers all of the manufacturer's products to the best of the manufacturer's knowledge. Manufacturers who are unsure of the status of a product should report it as code AI until the assessment is completed.

The request for web site posting of product information on noncompliance status or total compliance certification is designed to provide an opportunity for manufacturers to communicate and better serve customers in a responsible and proactive manner, and avoid the necessity for manufacturers and vendors to field numerous calls and letters from individual organizations. The information you provide will prevent Year 2000 problems from endangering the nation's patient care and health research activities.

The public will be informed via the web page that:

There is no assurance that manufacturers who fail to respond to this request are Year 2000 compliant.
The information that resides on this web site has been provided by the manufacturers of biomedical equipment. Users or potential purchasers of equipment should independently verify compliance of specific, critical products.

If you have questions regarding this survey or web site, you may contact Gayle Finch, Director of the Office of Information Technology Planning and Investment, Office of the Secretary on 202-690-5515. Questions on technical aspects of data submission or electronic communications should be addressed to Stuart Carlow, Director of the Division of Information Dissemination, Center for Devices and Radiological Health, FDA at 301-594-4754 or via e-mail to sac@cdrh.fda.gov.