Medical Devices; Quality System Regulation Amendments

Quality requirements (TBT); Protection of human health or safety (TBT); Harmonization (TBT); Reducing trade barriers and facilitating trade (TBT)

Medical devices

Link to ePing

03.120 - Quality; 03.120 - Quality; 11.040 - Medical equipment; 11.040 - Medical equipment

Human health

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 820This 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 https://www.regulations.gov/docket/FDA-2021-N-0507/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. 

1:File here 2:File here 3:File here 4:File here 5:File here

EN:File here

ES:File here

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