Medical device alert

On 22 February 2013, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a draft guidance titled, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff, which describes how to differentiate violative devices from non-violative devices with respect to Corrections and Removals (21 C.F.R. Part 806), as well as Voluntary Recalls (21 C.F.R. Part 7). The purpose of the guidance is to clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the definition of a medical device recall, and to identify the associated regulatory reporting requirements for each type of activity.

The guidance does not address when changes to marketed devices trigger new product submissions. In addition, the guidance does not address issues regarding radiological health devices  concerning radiation defects or failures to comply with radiation safety performance standards described in 21 C.F.R. Parts 1020-1050…

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