The FDA managed to wrap up the guidance for benefit-risk determinations for compliance action in six months, a much shorter turn-around than seen in a number of recent medical device guidances. The agency unveiled the final version just in time for the holiday season, but device makers should be aware that this guidance states that one company’s problem can quickly become a problem for other device makers.
Alignment with ISO 14971 spotty
The agency stated in the June 2016 draft that the intent was to “provide clarity” for the agency and device makers on the factors to be considered regarding compliance and enforcement activities for devices that seem to be emitting problematic safety signals in the postmarket realm. Among the factors taken into consideration is the prospect that a withdrawal would create a shortage of essential medical devices, and the FDA indicated from the outset that both short- and long-term considerations must be taken into account when examining whether the benefit-risk profile of a device seems to suggest a need for compliance and/or enforcement activity.
The final guidance did nothing to align more tightly with ISO 14971 than the draft, a consideration cited by several trade associations as a significant problem with the draft. In both versions of the guidance, the FDA acknowledged the roles of both ISO 14971 and 21 CFR Part 820 in terms of total life cycle management, but the final guidance has little more to say about this other than to concede that alignment of the Quality Systems Regulations with the ISO standard is limited.
Device makers had argued through their trade associations that the failure to provide more specific information on this score makes it difficult at best to anticipate how compliance with the ISO standard would satisfy the agency when using 14971 in determining how to address a problematic or potentially problematic device, all to no apparent avail.
Why your problem becomes my problem
Perhaps of greater interest to device makers, however, was the section appearing in both versions stating that any hazards associated with a specific device could be extrapolated to other devices made by that manufacturer, and to any similar devices made by other manufacturers. The FDA did not specifically state that any compliance and enforcement activities mandated by the agency would necessarily extend to similar devices made by other companies, but those in the life science industries are all too aware that bad news announced by a federal agency can quickly become a contagion in the court of public opinion. In some circumstances, the FDA may feel pressured to act on an individual company’s offerings even in the absence of a clear safety signal specific to that company’s device.
It might be pertinent to point out that members of the Senate and the House of Representatives occasionally dive into the med tech regulation pool, such as when Sen. Patty Murray (D-Washington) introduced the Preventing Superbugs and Protecting Patients Act of 2016 despite that the agency had mandated postmarket surveillance studies of duodenoscopes in late 2015. The savvy device manufacturer might consider the possibility that the FDA would prefer to undertake more vigorous – and potentially more sweeping – enforcement action rather than deal with further congressional meddling when adverse events reports begin to spike for a competitor’s offerings.