FDA is streamlining the reporting process for medical device removals and corrections, according to a recent article in Regulatory Focus. Known as "806 reports," these filings disclose 15 data points on issues related to manufacturing, marketing, and corrective action. Manufacturers must submit them within 10 days of the safety removal or correction. Traditionally, 806 reports were submitted by mail, but the new proposal creates a voluntary electronic submission process.
Matthew R. Bowles assisted in the preparation of this Update.
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