CDRH 2022 Annual Report
Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device safety.
Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device safety.
New informational video about the new category of OTC hearing aids, prescription hearing aids, and how they are different from personal sound amplification products.
CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and one of its subsidiaries, Aizu Olympus Co, Ltd., following facility inspections.
Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation.
"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