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HHS/FDA RIN: 0910-AI21 Publication ID: Fall 2022 
Title: Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids 
Abstract:

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. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 800    21 CFR 801    21 CFR 808    21 CFR 874   
Legal Authority: 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    ...   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    08/18/2020 
Timetable:
Action Date FR Cite
NPRM  10/20/2021  86 FR 58150   
NPRM Comment Period End  01/18/2022 
Final Rule  08/17/2022  87 FR 50698   
Final Rule Effective  10/17/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ian Ostermiller
Regulatory Counsel, Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993
Phone:301 796-5678
Email: ian.ostermiller@fda.hhs.gov