FDA Issues Final Rule on Medical Device Adverse Event Reporting

Reports on medical device adverse events will soon be required to be submitted electronically, according to a final rule issued by the U.S. Food and Drug Administration, effective Aug. 14, 2015.

Previously, manufacturers had the choice to submit medical device adverse event reports on paper or electronically.

Electronic submission of reports will save manufacturers the cost of submitting paper forms as well as make the information more quickly available to the FDA. In turn, the FDA can analyze and communicate information about adverse events to the public more efficiently.

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