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HHS/FDA | RIN: 0910-AI21 | Publication ID: Spring 2022 |
Title: Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations | |
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Yes | Unfunded Mandates: No |
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:
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: State |
Small Entities Affected: No | Federalism: Yes |
Included in the Regulatory Plan: Yes | |
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 |