The FDA's final guidance on medical device recalls and associated reporting requirements omits the most pernicious proposal of the draft guidance, but is of little utility and "will probably soon be forgotten," according to the FDA Law Blog, written by Hyman, Phelps & McNamara attorneys.
The guidance focuses on distinguishing between device recalls and device enhancements. Unlike a recall, an enhancement is designed to improve the quality of a device by making a modification that is "not a change to remedy a violation of the FD&C Act (Federal Food, Drug and Cosmetic Act) or associated regulations enforced by the agency," according to the final guidance.
Enhancements include, but are not limited to "changes designed to better meet the needs of the user, changes to make the device easier to manufacture, changes to improve a non-violative device's safety or performance, and changes to the appearance of the device that do not affect its use."
The final guidance eliminates a proposed reporting requirement for device enhancements. Attorney Jeffrey Shapiro supports the move. Upon last year's the release of draft guidance, he wrote that the requirement exceeds FDA's statutory mandate. Industry bigwigs like AdvaMed and Boston Scientific ($BSX) also joined the fray and protested the additional mandate. Reporting of recalls is already required under Part 806 of the FD&C Act.
Otherwise, Shapiro finds little to cheer about in the final guidance. It does not provide clarity around what types of minor violations (or "market withdrawals") are not subject to legal action by the agency, he said.
In addition, "it is troubling that FDA's final guidance definition of 'device enhancement' still does not explicitly state whether modifications within this definition are to devices already in the field or confined to future production," Shapiro writes.
"If FDA is impliedly taking the position that modifications of future production only can be a correction subject to Part 806 (reporting requirement), that is a bold and controversial proposition that the agency should forthrightly state and defend. On the other hand, if FDA is not taking this position, then this guidance should have said so, if only to correct the misimpression left by the draft guidance," Shapiro continues.
Like many other final guidances, this one omits the least industry friendly sections from the draft and is useful reading for those uninitiated, or only somewhat familiar with, the topic of recall reporting requirements. But whether intentionally or not, it does not satisfy subject matter experts.
- read the final guidance
- here's the FDA Law Blog post and the draft guidance