IOM report regarding 510(k) clearance process released, raises more questions than it answers

The highly-anticipated Institute of Medicine (IOM) report, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, evaluating the 510(k) clearance process was released Friday morning to a substantial amount of controversy. As described in more detail below, the primary conclusion of the report is that the agency should completely dismantle the existing 510(k) program for class II devices and replace that paradigm with a new system explicitly based on safety and effectiveness. Both FDA and industry have signaled their objections to this recommendation and it seems unlikely it will be implemented, at least in the near-term. However, the IOM report does present a few limited but very high-level recommendations that could be adopted within the current framework. It is anticipated that considerable public debate will precede any action on these recommendations, as the agency has announced its intention to collect comments and hold at least one public meeting, before moving forward.

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