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U.S. Department of Health and Human Services

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Summary: Medical Device Reporting: Electronic Submission Requirements (Final Rule)

The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Regulatory Impact Analysis

Medical Device Reporting: Electronic Submission Requirements (PDF - 82KB)

Federal Register: 79 FR 8832-8855, February 14, 2014

Docket: FDA-2008-N-0393