FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
Posts tagged as “US FDA”
FDA eSTAR Pilot Program
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate Draft guidance – Product Labeling for Laparoscopic Power Morcellators
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
Cell Phone Safety: FDA Releases Literature Review, Web Page Updates
FDA Will Hold A Public Workshop to Discuss Good Simulation Practices in Health Technologies
Public Meeting – Communications About the Safety of Medical Devices
FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets
Radiology Devices: Reclassification of Medical Image Analyzers
FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards