WTO notification · TBT
United StatesAdopted, according to its latest notice
Official title
Medical Devices; Quality System Regulation Amendments
The United States issued an addendum on 8 December 2025 to the earlier TBT notification G/TBT/N/USA/1839. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 24 February 2022. The comment period closed on 24 May 2022.
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Medical devices
Latest notice (G/TBT/N/USA/1839/Add.2, 8 December 2025)
The latest notice says the measure was adopted or published.
Medical Devices; Quality Management System Regulation Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule ''Medical Devices; Quality System Regulation Amendments'' (QMSR Final Rule) (notified as G/TBT/N/USA/1839/Add.1). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations. This rule is effective 2 February 2026. 90 Federal Register (FR) 55978, 4 December 2025; Title 21 Code of Federal Regulations (CFR) Parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892: This final rule; technical amendments is identified by Docket Number FDA-2025-N-4635. The Docket Folder is available from Regulations.gov at and provides access to primary documents. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1839 are identified by Docket Number FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at 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.
Proposed rule - The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We propose to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking we also propose additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products. This action, if finalized, will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1839/Add.2
Medical Devices; Quality Management System Regulation Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule ''Medical Devices; Quality System Regulation Amendments'' (QMSR Final Rule) (notified as G/TBT/N/USA/1839/Add.1). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations. This rule is effective 2 February 2026. 90 Federal Register (FR) 55978, 4 December 2025; Title 21 Code of Federal Regulations (CFR) Parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892: This final rule; technical amendments is identified by Docket Number FDA-2025-N-4635. The Docket Folder is available from Regulations.gov at and provides access to primary documents. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1839 are identified by Docket Number FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at 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.
CorrigendumG/TBT/N/USA/1839/Add.1/Corr.1
Medical Devices; Quality System Regulation Amendments
The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on 2 February 2024 (notified as G/TBT/N/USA/1839/Add.1). In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations. Effective 2 February 2026 89 Federal Register (FR) 82945, Title 21 Code of Federal Regulations (CFR) Part 820: This action and previous actions notified under the symbol G/TBT/N/USA/1839 are identified by Docket Number FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at 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.
AddendumG/TBT/N/USA/1839/Add.1
Medical Devices; Quality System Regulation Amendments
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients. This rule is effective 2 February 2026. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register 2 February 2026. Title 21 Code of Federal Regulations (CFR) Parts 4 and 820 This final rule and the proposed rule notified as G/TBT/N/USA/1839 are identified by Docket Number FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at and provides access to primary and supporting…
Regular notificationG/TBT/N/USA/1839
Comment deadline: Closed on 24 May 2022
Medical Devices; Quality System Regulation Amendments
Proposed rule - The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We propose to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking we also propose additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products. This action, if finalized, will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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