Regulatory Education for Industry (REdI) Annual Conference 2023
Learn directly from FDA regulatory experts in medical product centers: devices, drugs, and biologics.
Medical Devices
Topic Paragraphs
Medical Device Updates
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests
The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit.
OTC Hearing Aids: What You Should Know
What you should know before and after buying an OTC hearing aid.
May is Better Hearing and Speech Month
Hearing loss affects over 30 million people in the U.S. and can have significant impact on the communication, social participation, and overall health and quality of life. Learn more about general information on hearing aids, their benefits, types of hearing loss, procedures to improve hearing, and what you should know before and after buying OTC hearing aids.
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End of the COVID-19 Public Health Emergency
The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023.
Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met.
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