New Guidance on Medical Device Reporting Supersedes Guidance in Use Since 1997

On November 8, 2016, FDA issued Medical Device Reporting for Manufacturers Guidance for Industry and Food and Drug Administration Staff noting that the draft was issued on July 9, 2013 and that the new guidance supersedes Medical Device Reporting for Manufacturers dated March 1997.

According to the Notice of Availability (81 FR 78603) “The draft of this guidance was made available in the Federal Register on July 9, 2013 (78 FR 41069), and the comment period closed October 7, 2013. FDA reviewed and considered all public comments received and revised the guidance as appropriate. This document supersedes the draft entitled, “Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff,” dated July 9, 2013, and the previous guidance on this topic, “Medical Device Reporting for Manufacturers,” issued March 1997.” The new guidance also notes that “FDA published a final rule entitled “Medical Device Reporting: Electronic Submission Requirements” on February 14, 2014 (79 Fed. Reg. 8832). FDA has modified this guidance based on that final rulemaking to ensure that the recommendations in this guidance are consistent with the final rule.”

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