On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the draft guidance, FDA intends to clarify how to determine whether a change made to a marketed medical device should be considered a recall or a product enhancement and whether the recall or product enhancement should be reported to FDA. Comments on the draft guidance must be submitted by May 23, 2013 via mail or electronically through Regulations.gov. All comments should identify docket number FDA-2013-D-0114.

The draft guidance is intended to help manufacturers to answer two questions: (1) whether a change to a medical device constitutes a recall or a product enhancement, and (2) whether the change to the device must be reported to FDA. FDA acknowledges that manufacturers often undertake continuous improvement activities related to medical devices. These changes “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.” FDA does not want to discourage these improvements and recognizes that not all such changes necessarily constitute a recall. However, when such product enhancements are made to improve the safety of the device, the product enhancements may nevertheless need to be reported under the corrections and removals requirements of 21 C.F.R. Part 806.