The FDA’s recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX). Both organizations submitted written responses to the FDA’s draft guidance, warning that the proposal hadn’t met its intention of clearing up the difference between a technology change that merits an official recall and one that counts as a “product enhancement.”
Part of the problem has to do with the term “product enhancement” itself as well as other terms that the FDA hadn’t fully defined, Bloomberg BNA reported. “We believe that distinguishing between ‘correction’ and ‘product enhancement’ and eliminating any overlap between them will help reinforce the understanding that modifications undertaken to correct violative products are recalls, whereas product modifications undertaken as part of a firm’s continuous improvement and sustaining engineering efforts are ‘product enhancements,’ and not a recall.”
FDA looks to clarify the difference between a voluntary recall and a product enhancement
On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” (Docket No. FDA-2013-D-0114) (Draft Guidance). The purpose of the Draft Guidance, according to FDA, is to “clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that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.” (Draft Guidance, lines 90-93).
The Draft Guidance applies only to voluntary recalls, whether they are commenced by the manufacturer on its own initiative or as the result of a formal request by FDA, as opposed to mandatory recalls. Mandatory recalls are governed by the Food, Drug and Cosmetic Act (the “FDCA”), 21 U.S.C. §360h. Voluntary recalls are governed by related regulations found at 21 CFR, part 7.
The distinction between whether an action constitutes a “recall” or a “product enhancement” is significant, because product recalls necessitate submission of a correction and removal report (also known as an “806 report”) to FDA (if the violation at issue may present a risk to health), often generate negative publicity, could damage the company’s reputation with customers, could reduce revenue of the product line or lines associated with the recall, and could have implications in subsequent lawsuits. What medical device companies previously viewed as improvements could now be considered recalls in some circumstances. Changes to products that constitute recalls can range from labeling changes to updates to instructions for implantation to component substitutions.
REFERENCE: Mass Device; May 30, 2013 by Arezu Sarvestani