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Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Notices FDARA also directed FDA to update and finalize the draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, issued on November 7, 2013. To fulfill this requirement of FDARA, FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance reflects the current regulatory framework for hearing aids and summarizes the new regulatory framework for hearing aids in the proposed rule. After the proposed rule is finalized, this guidance will be updated accordingly so that it only reflects the final regulatory framework for hearing aids.
This guidance identifies current applicable legal requirements under the Federal Food, Drug, and Cosmetic Act for hearing aids and for PSAPs. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.

www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an electronic copy of Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document.
Please use the document number 1832
and complete title to identify the guidance you are requesting.

II. Electronic Access
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA
regulations have been approved by OMB
as listed in the following table:

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance is also available at https
www.regulations.gov and at https

III. Paperwork Reduction Act of 1995

21 CFR parts
Topic
800, 801, and 809
803

Medical Device Labeling Regulations
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting.
Premarket notification
Premarket Approval Application
Electronic Products

807, subpart E
814
1000 through 1050

This draft guidance also refers to proposed collections of information described in FDAs proposed rule on Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. The proposed collections of information in the proposed rule are subject to review by
lotter on DSK11XQN23PROD with NOTICES2

This draft guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The draft guidance, when finalized, will represent the current thinking of FDA
on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

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OMB under the PRA 44 U.S.C. 3501
3521. As required by the PRA, FDA has published an analysis of the information collection provisions of the proposed rule as published elsewhere in this edition of the Federal Register and has submitted it for OMB approval.

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Dated: October 12, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202122612 Filed 101921; 8:45 am BILLING CODE 416401P

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