The FDA has commissioned the Institute of Medicine to study the premarket clearance process for medical devices, according to a release from the FDA.
The $1.3 million IOM review will be asking whether the current clearance process protects patients and promote innovation, and, if not, whether any legislative, regulatory or administrative changes are needed.
The IOM will hold two public workshops on the matter in the next nine months and publish a final report in March 2011.
Read the FDA’s release on its medical device clearance process.
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