The program will provide more transparency to patients, physicians, and the medical device industry on how the FDA determines whether to approve an HDE application for a device that is meant to treat or diagnose populations w/ uncommon medical conditions. https://go.usa.gov/xV9Yx  

The program will provide more transparency to patients, physicians, and the medical device industry on how the FDA determines whether to approve an HDE application for a device that is meant to treat or diagnose populations w/ uncommon medical conditions. https://go.usa.gov/xV9Yx 
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news
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