- Distinguishing Medical Device Recalls from Product Enhancements
- March 11, 2013
- Law Firm: Alston Bird LLP - Atlanta Office
On February 22, 2013, FDA issued a Draft Guidance, “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements,” in order to clarify when a potential change to a device constitutes a medical device recall and to distinguish these from instances that constitute mere “product enhancements.” The Draft Guidance explains how to differentiate between a device recall and a product enhancement and describes the respective reporting requirements for each.
Recall regulations require removal or correction of a marketed product by the manufacturer to correct a product defect or performance failure that renders the product violative and poses a public health risk. In these instances, manufacturers are required to comply with the recall reporting requirements under 21 C.F.R. Part 806, including a correction and removal report (“806 report”). “Recalls” do not include “market withdrawals” or “stock recoveries” (those terms are defined in 21 C.F.R. Parts 7 and 806). The purpose of this Draft Guidance is to clarify that recalls also do not include “product enhancements.”
Although FDA regulations do not define “product enhancement,” for the purposes of the Draft Guidance, FDA defines a product enhancement as a change or improvement to a non-violative device as part of continuous device improvement activities. This includes changes designed to better meet the needs of the user, changes that make the product easier to manufacture and aesthetic changes that do not affect its use. The key distinguishing factor between a product enhancement and a recall is that a product enhancement is not a change to remedy a violation of the Federal Food, Drug and Cosmetic Act (FCDA).
In order to determine whether the change to the device does not reach the higher threshold of a product recall, the manufacturer must determine whether the device can be marketed without change and still be in compliance with FDA regulations. A “Recall Decision Making Flow Chart” is provided (Draft Guidance at 8). Manufacturers should ask themselves the following three questions (before making a change):
Is the device failing to perform as intended or failing to meet any specification?
Is the device labeling false, misleading or otherwise inaccurate?
Is the device otherwise out of compliance with FDA regulations?
If the answer is affirmative for any of these questions, the change would constitute a product recall; however, if the answer is negative for all three questions, the change constitutes a mere product enhancement. Once a manufacturer has determined that the change is a product enhancement, the Draft Guidance explains that the 806 report is still required if the correction or removal is initiated “to reduce a risk to health posed by the device” (e.g., a design change to improve a product’s safety profile) unless all the information has previously been provided under FDA’s medical device reporting requirements.
The Federal Register notice states that comments should be submitted by May 23, 2013.