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UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

August 6, 1997

**Addressees**

All U.S. Nuclear Regulatory Commission medical licensees, veterinarians, and manufacturers/ distributors of medicaldevices.

**Purpose**

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to inform licensees of a letter from theU.S. Department of Health and Human Services, Food and Drug Administration (FDA), to medical device manufacturers,about the Year 2000 problem. It is expected that recipients will review this information for applicability to their facilitiesand consider actions, as appropriate, to avoid potential problems. However, suggestions contained in this informationnotice are not NRC requirements; therefore, no specific action nor written response is required.

**Description of Circumstances**

In a letter dated June 25, 1997 (attached), the FDA reminded medical device manufacturers that some computer systemsand software applications currently used in medical devices, including embedded microprocessors, may experienceproblems as a result of the turn to the new century. In addition, the letter indicated that computer-controlled design,production, or quality control processes could be adversely affected.

**Discussion**

The FDA requires the manufacturers it regulates to investigate and correct problems with medical devices that present asignificant risk to public health. To ensure the continued safety and effectiveness of medical devices, the FDArecommended that manufacturers take the following actions: (1) ensure that medical devices submitted for premarketapproval can perform date recording and computations that will not be affected by the Year 2000 problem; (2) conducthazard and safety analyses on currently manufactured devices to determine whether device performance could be affectedby the Year 2000 problem, and, if so, take appropriate steps to correct production and help customers who have purchasedsuch devices; and (3) check design, production, and quality control processes to ensure year 2000 compliance. This letteralso applies to those manufacturers that use radioactive material in their medical devices.

If there are any questions about medical device manufacturers' responsibilities regarding the Year 2000 problem, contactthe FDA's Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, by phone, at 1-800-638-2041 or fax, at 301-443-8818. Also, an electronic copy of the letter is available on the FDA's World Wide Web homepage at http://www.fda.gov/cdrh.

**Related Generic Communications**

NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on December 24, 1996,addressed the Year 2000 problem and its applicability to NRC licensed programs.

This information notice requires no specific action nor written response. If you have any questions about the information inthis notice, please contact the technical contact listed below or the appropriate regional office.

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