The second guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Find out more. https://go.usa.gov/xdyPC  

The second guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Find out more. https://go.usa.gov/xdyPC 

Source: Food and Drug Adminstration (FDA): CDRHNew - February 25, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news