On July 9, the FDA issued a draft guidance on manufacturers’ responsibility to report adverse effects from their products: “Medical Device Reporting for Manufacturers,” for the purpose of seeking comments. Comments and suggestions should be submitted regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

This draft guidance document attempts to explain: the purpose of the regulation, to whom it explicitly applies, what “Medical Device Reporting (MDR) reportable events” means, where to get help in reporting, what “user error” means, what information must be included in the report, and more.

The FDA defines “MDR reportable events” as “events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” In addition, even in cases when human error is suspected in the operation of the device, the event still must be reported.

When final, this document will supersede “Medical Device Reporting for Manufacturers” dated March 1997.

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