FDA Throttles Device Approval

The FDA is moving at two speeds in the medical device approval process. On the one hand, the agency is taking a critical look at the 510(k), expedited approval process, which has come under fire for being too lenient. The process will certainly see some change, given the pressure ensuing from high profile device failures and the changing of the guard at the FDA.

On the other hand, the FDA has moved to allow the use of Bayesian statistics that will potentially expedite device approvals by allowing manufacturers to combine trial data in support of device safety and efficacy.  (See link.)

It may be a bit optimistic on the part of industry to hope that Bayesian statistics will fully counter the pending 510(k) process changes, but the healthcare industry will take any good news it can.

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