The @US_FDA also issued a final guidance on The Abbreviated 510(k) Program. Together, these guidance documents will superseded “ The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications ” guidance: https://go.usa.gov/xVnGT   pic.twitter.com/NbRqWru8kB

The @US_FDA also issued a final guidance on The Abbreviated 510(k) Program. Together, these guidance documents will superseded “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” guidance: https://go.usa.gov/xVnGT  pic.twitter.com/NbRqWru8kB

Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news