Is "substantially equivalent" good enough for approval of new medical devices?

I think the American public would be shocked if they knew the guts of what was in the GAO report yesterday, "FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process."

The report suggests that FDA review and approval of new medical devices has been lax, allowing companies to get approval through an easier process whereby they only had to show their idea/product was "substantially equivalent" to an existing product on the market. But that loophole was only meant for the smaller toys of the medical arms race. It wasn't meant for metal hip joints, pacemaker electrodes and pedicle screws for spinal surgery - all of which slipped through the easier review process, according to the GAO.

And journalists and the public should take this into account when they hear or report news of FDA approval of some devices. It's NOT terribly big news, in my view, to trumpet FDA approval of something that's only judged substantially equivalent to something already on the market.

NBC, for one, gave a big chunk of precious airtime to FDA approval of a laser hair comb. Whoopee. Our review on showed that it was only judged to be substantially equivalent to 10 other products already on the market!!!

Breakthrough? Depends on how you spell hype.

About this Entry

This page contains a single entry by Gary Schwitzer published on January 16, 2009 8:47 AM.

"How in the hell can a guy walk out in 20-below zero and not wake up?" was the previous entry in this blog.

Gaping hole in med school conflict of interest policies is the next entry in this blog.

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