This article was originally published in The Gray Sheet
FDA audit via outside contractor of a sample of potentially high-risk medical device (PHRD) manufacturers for Y2K compliance is expected to be completed by September, FDA says. The PHRD audit is unrelated to a June 18 survey sent by FDA, seeking input on Y2K distribution/supply line compliance, as reported in "The Gray Sheet" (July 5, p. 15). For a full listing of FDA's PHRDs see FDA's website
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