CDRHNew
Date: August 1, 2014
The following new items were added to the CDRH web pages on July 31, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Companion Diagnostics
- FDA Voice Blog: Curbing Risk, Not Medical Innovation, in Personalized Medicine
- In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements - Draft Guidance for Industry and Food and Drug Administration Staff
- Laboratory Developed Tests
- Notification to Congress: FDA’s Laboratory Developed Tests Framework
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