Regulatory Counsel, Center for Devices and Radiological Health

0910-AI21 202204 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations

FDA is establishing an over-the-counter category of hearing aids to promote the availability of additional kinds of devices that address perceived mild to moderate hearing loss. FDA is also making related amendments to the current hearing aid regulations, the regulations codifying FDA decisions on State applications for exemption from preemption, and the hearing aid classification regulations.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 800 21 CFR 801 21 CFR 808 21 CFR 874 21 U.S.C. 321 21 U.S.C. 331 to 334 21 U.S.C. 351 and 352 21 U.S.C. 360 21 U.S.C. 360c to 360e Pub. L. 115-52, 131 Stat. 1065-67 21 U.S.C. 360i to 360k 21 U.S.C. 360l 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 ... Statutory NPRM 08/18/2020 Yes NPRM 10/20/2021 86 FR 58150 NPRM Comment Period End 01/18/2022 Final Rule 07/00/2022 Undetermined No State Yes No No Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993