On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance has the potential to increase the number and frequency of recalls. Device manufacturers should pay close attention to FDA’s proposed changes in this area, as litigation and government investigations alleging violations of recall-related regulations have been increasing.

Newly Created Term – “Product Enhancement” -

FDA regulations define a recall as the “removal or correction of a marketed product that [FDA] considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.” 21 C.F.R. § 7.3(g). The term “product enhancement” does not appear in FDA regulations, but is defined in the draft guidance to mean a change to improve the performance or quality of a device that does not remedy a violation of the Food, Drug, & Cosmetic Act (“FDCA”).

The draft guidance sets forth a decision-making flow chart for distinguishing medical device recalls from product enhancements by asking such questions as...

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