On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal guidance on the medical device reporting (MDR) regulation since the final guidance the Agency issued in 1997 (hereinafter “1997 Guidance”),2 which the Draft Guidance will supersede once it has been finalized. Although the Draft Guidance is not final and the 1997 Guidance remains in effect, the Draft Guidance represents the Agency’s current thinking on MDR requirements and is “intended to update FDA’s policy and to further clarify FDA’s interpretations of the [MDR] regulation requirements . . . .” Given that the 1997 Guidance is more than sixteen years old and in some ways out of date, manufacturers should become familiar with the contents of the Draft Guidance and should consider complying with or commenting on its recommendations prior to its finalization. FDA is accepting comments on the Draft Guidance until October 7, 2013 (docket number FDA-2013-D-0743).
Draft Guidance Overview and Comparison to 1997 Guidance -
The Draft Guidance is written in a question-and-answer format, addressing: manufacturers’ reporting requirements; requirements for written procedures, recordkeeping, and public disclosure; specific issues and situations; and completing the Form 3500A used to report MDRs to FDA. Much of the content in the Draft Guidance closely tracks the language in the MDR regulations contained in 21 C.F.R. Part 803 and provides a general overview of manufacturers’ responsibilities for reporting adverse events to FDA. The Draft Guidance leaves much of the advice from the 1997 Guidance intact and expands upon that guidance, with a few notable changes.
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