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.
Medical Devices
Topic Paragraphs
Medical Device Updates
Hearing Aids - What to Know
New informational video about the new category of OTC hearing aids, prescription hearing aids, and how they are different from personal sound amplification products.
FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes
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.
Public Health Emergency Updates
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
Contact Us
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
(800) 638-2041
(301) 796-7100
Hours Available
Office of Communication and Education