FDA Distinguishes Medical Device Recall From Product Enhancement
Audet & Partners, LLP reports that the U.S. Food and Drug Administration (FDA) has issued new formal guidelines that are intended to clarify whether certain changes to marketed medical devices constitute a “recall” or “product enhancement.” This distinction is important to medical device manufacturers and marketers as “recalls” trigger specific reporting requirements with the FDA, while “product improvements” need not be reported to the FDA.
The key element of guidance provided by the FDA concerns whether the product change includes “a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 360h] or associated regulations enforced by the Agency.” Thus the FDA will treat as a “recall” and change to a product that may violate laws for which the FDA is responsible for administering.
The FDA guidance also sets forth specific questions which, answered in the affirmative, would suggest treatment as a “recall” rather than a product enhancement:
- Are the changes intended to resolve a failure to meet specification or to perform as represented?
- Is the labeling for the device false or misleading, does it fail to bear adequate directions for use, or does it otherwise violate the FD&C Act or FDA regulations?
Finally, the final guidance issued by the FDA, a medical device manufacturer need only submit a report to the FDA if the device correction was done to address a “risk to health.” If not, no formal report becomes necessary, and the company need only retain records of the action in question for two years.
You can click here to view a full copy of the FDA guidance.
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