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,...