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A Push Away From 510(k)?

By James M. Beck and Mark Herrmann

This morning's Washington Post, among other places, reports that there's a movement afoot to cause the FDA to review all high-risk medical devices through pre-market approval, rather than the less rigorous pre-market notification (or "510(k)") process.

That's a mixed bag.

This would surely increase the time it takes to get new devices on the market, which could, in some cases, hurt the public health.

But this would increase the amount of pre-market review by the FDA, which could, in some cases, protect the public health.

Here's what we add to the discussion: None of the articles that we've seen mentions that pre-market approval preempts later product liability claims (under Riegel v. Medtronic). Pre-market notification typically does not result in preemption (under Medtronic v. Lohr, 518 U.S. 470 (1996)).

While policy-makers are thinking about the appropriate review process, they might also think about the legal implications of that choice after a device is being sold.

Full post as published by Drug and Device Law on January 16, 2009 (boomark / email).