FDA Orders Study of Premarket Clearance Process for Medical Devices
November 13, 2009 by Beckers ASC Review
Filed under Becker's ASC Review
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.
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A post by "Becker's ASC Editor" http://www.beckersasc.com Becker's ASC Review is a bimonthly publication that offers general business, legal and clinical guidance on topics including joint-ventures, development and expansion, and regulatory and compliance issues. |
