Dear Medical Device Manufacturer:

This is to remind you that some computer systems and software applications currently used in medical devices, including embedded microprocessors, may experience problems beginning January 1, 2000 due to their use of two-digit fields for date representation. In addition to adversely affecting the functioning of some devices, the two-digit date format could also affect computer-controlled design, production or quality control processes.

To ensure the continued safety and effectiveness of these devices, we are recommending the following actions:

• For future medical device premarket submissions, manufacturers should assure that the products can perform date recording and computations that will be unaffected by the year-2000 date change.

• For currently manufactured medical devices, manufacturers should conduct hazard and safety analyses to determine whether device performance could be affected by the year-2000 date change. If these analyses show that device safety or effectiveness could be affected, then appropriate steps should be taken to correct current production and to assist customers who have purchased such devices.

• For computer-controlled design, production and quality control processes, manufacturers should assure that two-digit date formats or computations do not cause problems beginning January 1, 2000.

The following information should help answer questions about premarket submission requirements relating to year-2000 changes:

• Manufacturers need not submit Premarket Approval Application Supplements for Class III devices to document that they have addressed year-2000 problems, provided that the modifications made in the device do not change other aspects of its performance.

• Manufacturers need not submit a new 510(k) (premarket notification) for year-2000 changes to an existing device, provided that the changes do not affect safety and effectiveness. This is in keeping with the information provided in the Office of Device Evaluation guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" available from the Division of Small Manufacturers Assistance and the FDA/CDRH World Wide Web home page. (Note that year-2000 changes should be included in any future 510(k) submission for a significant change to the device.)

Manufacturers should also note that under the previous GMP regulation and the current Quality System Regulation, effective June 1, 1997, they must investigate and correct problems with medical devices that present a significant risk to public health. This includes devices that fail to operate according to their specifications because of inaccurate date recording and/or calculations. Section 518 of the Food, Drug and Cosmetic Act requires notification of users or purchasers when a device presents an unreasonable risk of substantial harm to public health.

If you have questions regarding these issues, please contact the CDRH Division of Small Manufacturers Assistance by phone at 800-638-2041, or by fax at 301-443-8818. In addition, information concerning medical device regulatory issues may be found on the CDRH home page, at http://www.fda.gov/cdrh.

(Updated June 20, 1997)