By Jeffrey K. Shapiro –
FDA has recently finalized the guidance document, now titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” We were critical of the draft guidance, especially the proposal for a new, extra legal reporting requirement for device enhancements (see our previous post here).
Thankfully, the final guidance does not include this proposal. The main thrust of it is that one should distinguish a recall from an enhancement by looking at whether the device modification is intended to address a violation of the Federal Food, Drug, and Cosmetic Act against which the agency would take action versus a change that does not address such a violation.
This concept was present in the draft guidance but is presented more forcefully. It is a fairly obvious point that did not require a guidance. On the really difficult questions, the final guidance punts (just like the draft guidance did).
For example, a “market withdrawal” is by definition a correction or removal involving a minor violation not subject to legal action by the agency. The determination as to whether a violation is “minor” is, in some cases, not easy. A device that fails to meet specifications or perform as represented is generally considered adulterated or misbranded, and action to address such issues would be a recall rather than an enhancement. However, there are many ways in which performance issues can arise with a device that are not addressed in the specifications or marketing representations. The final guidance does not discuss these situations.
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. The examples do not clarify this point. The issue of distinguishing a recall from an enhancement (which is the point of this final guidance) should arise only if a firm is correcting or removing devices in the field. If a firm is modifying future production only, under the regulatory definitions in 21 C.F.R. Parts 7 and 806, there is not a correction or removal, and a Part 806 reporting requirement cannot apply. (This issue was discussed at length in our post on the draft recall guidance.)
If FDA is impliedly taking the position that modifications of future production only can be a correction subject to Part 806, 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. A guidance is supposed to clarify regulatory requirements, not introduce new uncertainties.
In the end, the final guidance does not have the worst features of the draft guidance, for which industry should be grateful. At the same time, it does not clarify much or provide much useful guidance, and it will probably soon be forgotten. And so, a guidance episode that started with a loud bang, ends in a soft whimper.