Drugs and Devices : Comparison of European and U.S. Approval …
https://www.sciencedirect.com/science/article/pii/S2452302X16300638
Aug 01, 2016 · Approval of medical devices in both the EU and the United States share some similarities ().The FDA assigns devices to 3 main regulatory classes: low risk or Class I, moderate risk or Class II, and high risk or Class III ().In the United States, a Class I device requires merely a Premarket Notification without clinical trials, whereas Class III devices require clinical trials and/or other ...
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