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Medical Device Importers to Submit Electronic Adverse Event Reports Under FDA Rule

Monday, February 17, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule that, effective Aug. 14, 2015, will require medical device importers and manufacturers to submit mandatory reports of individual medical device adverse events, also known as medical device reports, in an electronic format that the FDA can process, review and archive. User facilities will have the choice of submitting MDRs electronically or in hardcopy.

The new electronic reporting requirement will apply to reports of deaths, serious injuries and malfunctions that must be reported to the FDA in initial five-day, 10-day or 30-day individual MDRs as well as information that must be reported in supplemental or follow-up reports. Limited exemptions from this requirement will be available but must be requested.

Finally, this final rule adds to Form FDA 3500A a question asking (a) whether the medical device is a single use device that has been reprocessed and reused on a patient and (b) if so, the name and address of the reprocessor.

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