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1997-10-11 12:42:13


FDA Warns Medical Device Manufacturers, Sort of



A June 25, 1997, letter from the Food and Drug Administration to manufacturers of electronic medical devices containing microprocessor chips warned about y2k, but it failed to mandate a response. This reminds me of the December 24, 1996, letter to America's 107 nuclear power plants from the Nuclear Regulatory Commission, which said: "This information notice requires no specific action nor written response." Maybe they are adopting the military's "don't ask, don't tell" strategy to deal with y2k.

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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.)


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