FDA Guidance​ Documents

The US FDA has produced the A-List of Guidance Documents that CDRH intends to publish in FY2020.  A-List: Prioritized Guidance Documents for FY2020  Final Guidance Topics Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Recommendations for Dual 510(k) and Clinical Laboratory Improvement […]