Data / Federal rules / 2024-01709
Medical Devices; Quality System Regulation Amendments
The Food and Drug Administration published this final rule in the Federal Register on February 2, 2024. It took effect on February 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.
What the agency says
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.
Key facts
- Document number
- 2024-01709
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- February 2, 2024
- Takes effect
- February 2, 2026
- Dates
- This rule is effective February 2, 2026. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register February 2, 2026.
- Docket
- Docket No. FDA-2021-N-0507
- Regulation ID (RIN)
- 0910-AH99
- Code of Federal Regulations
- 21 CFR 4; 21 CFR 820
- Topics
- Biologics; Drugs; Human cells and tissue-based products; Incorporation by reference; Medical devices; Reporting and recordkeeping requirements
- Pages
- 30
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on biologics · Rules on drugs · Rules on incorporation by reference · Published in February 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.