On October 15, 2014, the U.S. Food and Drug Administration (FDA) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (Final Guidance), revising a draft document that had been issued on February 22, 2013, Distinguishing Medical Device Recalls from Medical Device Enhancements and Associated Reporting Requirements (Draft Guidance). The Final Guidance, like the Draft Guidance, clarifies when a change to a device constitutes a recall, as well as the difference between a medical device recall and a "product enhancement." Notably, however, the FDA removed from the Final Guidance a discussion of several reporting requirements under 21 C.F.R. Part 806 for corrections that do not meet the FDA's definition of a recall, resulting in the change to the title of the guidance.
The Draft Guidance had proposed requiring reporting of any enhancement intended to reduce health risks, which could have forced medical device makers to report minor product changes that are not connected to recalls or serious safety concerns. In contrast, in the Final Guidance, the FDA removed a section requiring 806 reports for device enhancements and specifically stated that "[m]edical device enhancements do not require the submission of an 806 report." In addition, the FDA removed many of its proposals with respect to recall reporting requirements.
The removal of reporting requirements for medical device enhancements from the Final Guidance should be well received by industry not only because it lessens the need for additional reports to the FDA compared to the draft, but also because it adds a layer of clarity to the FDA's existing policy on the subject. While the FDA's position in the 2013 draft guidance, that some enhancements initiated to reduce a risk of health posed by the device, was unpopular with industry, it was not inconsistent with the practices of some manufacturers. By explicitly clarifying that medical device enhancements do not require the submission of an 806 report, the FDA has resolved an open question on which device manufacturers had previously reached differing conclusions.