In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed.
Among the most contentious recommendations being postponed was one for CDRH to develop guidance defining a subset of class II devices that would be called class IIb devices, for which clinical information, manufacturing information, or, potentially, additional evaluation in the post-market setting would typically be necessary to support a substantial equivalence determination. Other recommendations on hold include the ability to revoke 510(K) clearances and increased post-market surveillance.
And what, you ask, is holding up the 510(k)’s speedy arrival at the gate? A pending report from the Institute of Medicine (IOM; Washington) reviewing the pathway that isn’t expected out until this summer. If industry’s most recent experiences with IOM reports are a template, med-tech companies know that they cannot expect the same kid glove treatment that the FDA just gave them, and indeed, that is probably the reason that agency punted the more controversial recommendations, knowing full well that IOM could be the scapegoat for tighter restrictions on 510(k)s.
While it’s still unclear exactly what all the changes will be to the program after the IOM submits its review, it’s very likely that the standards will be more rigid than they have been in the past, potentially making 510(k) standards closer to their more rigorous cousin at FDA, the premarket approval (PMA), definitely not a good thing for the industry.
The ongoing review of the 510(k) program promises to clamp down on a regulatory path that device investors generally have regarded as a lower-cost, faster-paced path to commercialization for portfolio companies. The self-analysis by the agency — combined with the external review by the IOM — likely will steer some future 510(k) devices over to the more stringent and costly PMA path, but can venture capital investors and their companies afford the switch which would cost them millions of dollars more to complete clinical trials? Fasten your seat belts folks; this could be a bumpy landing.