Implications of I.O.M.


The other day, the Institute of Medicine came out with its long-awaited – and it seems to us, rather short on specifics – report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” on the FDA’s §510k “substantial equivalence” clearance process for (some/most) medical devices. Here’s a link to the report on the IOM’s website, where it is available for free, either to read or download. We’re not going to try competing with the FDA wonks on this one. If you’re interested in the product development/administrative/policy aspects of what the IOM recommended, we suggest that you go to someplace like the FDA Law Blog.

The IOM’s major recommendation is to ditch the §510k process altogether. We’re not going to discuss whether doing that is, a good idea (because that might make some devices safer) or a bad idea (because that might make a lot more devices more expensive and slower to get to market). We’re product liability lawyers, so we’re interested in what the impact of the recommendations might be on medical device litigation.

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