TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/1870/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

Objective

Consumer information, labelling (TBT); Protection of human health or safety (TBT); Quality requirements (TBT); Cost saving and productivity enhancement (TBT)

Product Covered

Quality (ICS code(s): 03.120); Anaesthetic, respiratory and reanimation (medical) equipment (ICS code(s): 11.040.10)

Document Notification

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HSCODE

ICSCODE

03.120 - Quality; 03.120 - Quality; 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Keywords

Human health; Human health

Specific Regions

Description

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.This rule is effective 18 December 2025, except for the amendments to Sec. Sec. 4.2 (amendatory instruction 2), 4.3 (amendatory instruction 3), and 4.4 (amendatory instruction 4) (21 CFR 4.2, 4.3, and 4.4), which are effective 2 February 2026. The incorporation by reference of certain material listed in this rule has been approved by the Director of the Federal Register as of 2 February 2026.89 Federal Register (FR) 51738, Title 21 Code of Federal Regulations (CFR) Parts 416201210211213230314, and 514_x000D_
https://www.govinfo.gov/content/pkg/FR-2024-06-18/html/2024-13190.htm_x000D_
https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdfThis final rule and the proposed rule notified as G/TBT/N/USA/1870 are identified by Docket Number FDA-2021-N-1333. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2021-N-1333/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.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/1870/Add.1

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