Green_Earth
Committee on Technical Barriers to Trade - Notification - United States - Hearing aids
日期:2021/10/21
作者:United States
文件編號:G/TBT/N/USA/1791
附件下載:GTBTN21USA1971.pdf
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NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: United States of America

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1820]

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov

3.

Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Hearing aids; Hearing aids (excl. parts and accessories) (HS 902140); Quality (ICS 03.120), Aids for deaf and hearing impaired people (ICS 11.180.15)

5.

Title, number of pages and language(s) of the notified document: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (42 page(s), in English)

6.

Description of content: Proposed rule - The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.

7.

Objective and rationale, including the nature of urgent problems where applicable: Consumer information, labelling; Prevention of deceptive practices and consumer protection; Protection of human health or safety; Quality requirements

8.

Relevant documents:

86 Federal Register (FR) 58150, 20 October 2021; Title 21 Code of Federal Regulations (CFR) Parts 800, 801, 808, and 874:
https://www.govinfo.gov/content/pkg/FR-2021-10-20/html/2021-22473.htm
https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf

This proposed rule is identified by Docket Number FDA-2021-N-0555. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2021-N-0555/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period.

Food and Drug Administration (FDA), Health and Human Services (HHS) Guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Notice of Availability:
https://www.govinfo.gov/content/pkg/FR-2021-10-20/html/2021-22612.htm
https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22612.pdf

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 18 January 2022

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

https://members.wto.org/crnattachments/2021/TBT/USA/21_6684_00_e.pdf