Friday, January 16, 2009

A Push Away From 510(k)?

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.


Ted Heise said...

Just wanted to point out one other effect on public health from converting 510(k) products to the PMA process. The level of evidence required for approval would no doubt increase. This would cause increased product costs, or decisions not to bring forward new or modified products because the approval costs could not be recouped.

Steve Zweig said...

This push to have 510(k) devices approved as PMA was tried in the mid 1990's by former FDA commissioner Kessler. It was a complete disaster. FDA new device approvals almost ground to a halt, and the medical device industry was severely damaged as a result. Meanwhile valuable resources were taken away from drug PMA approvals, possibly contributing to the disaster with Vioxx.