Alternatives To Scrapping 510(k)

Merrell Goozner

First posted 8/11/11 on Gooz News

The Institute of Medicine report on medical device regulation released two weeks ago called for scrapping the 510(k) process that allows for market entry of new devices if they’re shown to be “substantially equivalent” to already marketed devices. In a Perspective in today’s New England Journal of Medicine, committee members David R. Challoner, M.D. of the University of Florida and William W. Vodra, J.D., an attorney at Arnold & Porter, reiterated the reasoning of the report:

Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing 2 years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976. But that original device might never have been assessed for safety or effectiveness, nor perhaps would any subsequent ones in the family tree. . . We decided that the 510(k) process cannot be transformed into a premarketing evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to a previously cleared device.

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