On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final Recalls Guidance”). The guidance follows and revises a draft guidance document, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements, issued on February 22, 2013 (“Draft Guidance”).

Like the Draft Guidance, the Final Recalls Guidance is intended to clarify: (1) when a change to a device constitutes a recall; (2) the difference between a medical device enhancement and a recall; and (3) reporting requirements under 21 C.F.R. Part 806. The Final Recalls Guidance does not address when a change to a device (whether an enhancement or recall) requires an additional premarket submission, though it does emphasize that this determination should be made separately from the analysis of whether a change to a device is a recall. Although the primary content and focus of the Final Recalls Guidance remains unchanged from the Draft Guidance, there are some notable differences, which we describe in more detail below.