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Regulatory Education for Industry (REdI) Annual Conference 2023
Learn directly from FDA regulatory experts in medical product centers: devices, drugs, and biologics.
Learn directly from FDA regulatory experts in medical product centers: devices, drugs, and biologics.
The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit.
What you should know before and after buying an OTC hearing aid.
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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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.