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Medical Device Reporting Information Collections Under Review

Wednesday, August 26, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is requesting comments no later than Sept. 25 on the proposed extension of information collections concerning medical device reporting by importers, manufacturers and user facilities.

Importers and manufacturers of medical devices are required to report to the FDA when they receive or otherwise become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to death or serious injury or has malfunctioned in such a way that should the malfunction recur it would be likely to cause or contribute to a death or serious injury. Importers report deaths and serious injuries to the manufacturers and the FDA but only report malfunctions to the manufacturers (or the FDA if the manufacturers are unknown).

Medical device user facilities that receive or otherwise become aware of information that reasonably suggests that a device has or may have caused or contributed to (a) the death or serious illness of or (b) the serious illness of or serious injury to a patient of the facility must report that information to the FDA and the manufacturer (if known) within 10 working days after becoming aware of it. User facilities are also required to annually submit the number and summary of adverse events reported during the calendar year using form FDA 3419.

The FDA states that it has updated the burden estimates associated with these information collections to reflect revisions made by a final rule on the electronic submission of medical device reporting that became effective Aug. 14.

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