Device flight round trips, and other matters

September 17, 2016 – 9:23 AM | By Mark McCarty | No comments yet
The eventual fate of a camel under the 510(k) program

The eventual fate of the camel 510(k), right?

Never a dull moment in the world of medical devices and the Food and Drug Administration, is there? Sometimes the FDA is on the march, other times it seems the agency is about to be eclipsed by other forces. Don’t be fooled by the picture on the left, though. There is no FDA airline, or any intent by the agency to regulate airlines (none that we know of, anyway) other than the food they serve on board.

A case of regulatory leapfrog?

Device flight is the term used to describe a U.S. Device maker’s decision to go overseas with a new product offering in the expectation that the non-U.S. market would be run by a less stringent regulatory regime. Devices that flew from Europe to the U.S. may be heading back to the American market soon if recent developments are any indication.

As described in a recent edition of Medical Device Daily, the rewrite of the European Union’s Medical Device Directives is going to require that device makers re-examine their technical files and their quality systems, but existing CE authorizations will also expire sometime over the next four to five years. However, the notified bodies are not off the hook, either, as they will have to undergo re-certification.

If there’s an upside to all this, it might be that clinical trials will now be subject to more uniform requirements across the member nations, which might make it easier to use  data from outside of the U.S.for FDA regulatory filings.

Obviously there’s no guarantee that devices will suddenly “go home” like some spacefaring naif with an oversized cranium, but it certainly can’t hurt the prospects for manufacturing in the U.S., can it?

Tissue regs: FDA in bend-but-don’t-break mode?

The FDA has its hands full with the reaction to four guidances dealing with tissues for therapeutic uses. During the first of a two-day meeting on the subject, one speaker predicted the agency would face a legal challenge for a couple of the guidances. Mary Ann Chirba of the Boston College School of Law said the draft guidance for adipose tissue does not allow for the use of adipose tissue for non-structural purposes, a slight she said is egregious enough to undercut any presumption of deference by a court, presumably the District Court of the District of Columbia, where most cases involving the FDA are heard.

Maybe more damaging was the fact that Janet Marchibroda of the Bipartisan Policy Center said the FDA had on more than one occasion disregarded the statutory and regulatory meaning of “minimal manipulation.” This in addition to the Regrow Act, which would eliminate the need for phase III studies, is a mighty sure sign that the agency will have to play its hand carefully, especially given the widespread patient advocacy for regulatory forbearance.

What will the FDA do? No way to know, but I’m betting it does not pull the draft guidances. Stay tuned for this one.


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