FDA Issues Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements

Mon, 02/25/2013 - 2:38pm
Mass Device

The FDA issues draft guidance to help medical device companies figure out when to issue a recall in the case of an enhancement to an existing device.


The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn't need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."

The aim is to help companies figure out when a recall is warranted, according to the federal watchdog agency.

The FDA's Center for Devices & Radiological Health issued the draft guidance to "clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the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."



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