CHI White Paper Delicately Slams FDA 510(k) Review Proposal

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Yes, “delicately slams” is something of a contradiction in terms, but that’s really the best way to describe a new white paper from the California Health Institute (CHI) that takes pains to diplomatically say the FDA is about to really screw up device innovation in the United States.

A great chart on Page 7 of the white paper asserts, “less than one percent of devices that were cleared by the 510(k) process had been recalled.” It cites data that found “a total of 89 recalls in a five-year period out of an average of 19,873 submissions.”

In other words, the system needs a tweezer, not a sledgehammer.

“As the FDA, IOM and Congress consider reforms to 510(k), including some viewed as controversial—restricting use of multiple and split predicates, consolidating concepts of “indication for use” and “intended use,” creation of a subset of Class II devices, rescission authority, etc.—careful and deliberative consideration must be given to ensure that the process does not become more cumbersome, complex and costly, to the detriment of medical technology investment, innovation, and, ultimately, patient care,” CHI sums up in the white paper, “Upcoming Changes to the 510(K) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation.”

510(k) approval is huge for medical device firms. A glance at some company press releases just this week from Affymetrix, Beckman Coulter, Boston Scientific, and AutoGenomics demonstrates how high the business stakes are for these and other companies. For some, it means the difference between a great or poor quarter (and a CEOs relative job security) and for others it can determine whether the company remains in business or goes under.

The FDA has a pretty good searchable database that as of today contains listings of 510k approvals through September.

CHI and others are hoping that list won’t start getting shorter. We’ll keep you posted on this ongoing battle.

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