
Soft (Hydrophilic) Daily Wear Contact Lenses
Final guidance issued to identify performance criteria and testing methodologies for an additional device type under the Safety and Performance Based Pathway.
Final guidance issued to identify performance criteria and testing methodologies for an additional device type under the Safety and Performance Based Pathway.
CDRH issues statement to highlight importance of FDA finalizing two COVID-19 transition guidances for medical devices.
Questions and answers that provide background on the Mammography Quality Standards Act (MQSA) and mammography facilities.
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"Our center and the entire FDA stand ready to meet each challenge and opportunity in our continuing commitment to public health." - Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health