Recent Amendments
2023–2026 significant regulatory actions
| Date | Action | Regulatory basis | Key impact |
|---|---|---|---|
| Feb 2026 | QMSR effective | 21 CFR Part 820 amended | ISO 13485:2016 incorporated; all manufacturers must comply |
| May 2024 | LDT Final Rule published | 21 CFR Parts 807, 820, 803, 806, 830 amended | FDA to exercise oversight of laboratory-developed tests; 5-year phase-in from May 2024 |
| Feb 2024 | QMSR Final Rule published | 21 CFR Part 820 | Aligns QSR with ISO 13485:2016; replaces the 1996 QSR |
| 2024 | PCCP Guidance finalised | FD&C Act § 515C | Framework for Predetermined Change Control Plans for AI/ML SaMD |
| Oct 2023 | eSTAR mandatory | FDA programme requirement | All 510(k) and De Novo submissions required in eSTAR format |
| CDS Guidance 2022 | Clinical Decision Support Software Guidance finalised | FD&C Act § 520(o) | Clarifies when CDS software is and is not a regulated device |
QMSR transition (most significant recent change)
The Quality Management System Regulation (QMSR) final rule is the most significant amendment to 21 CFR Part 820 since the original Quality System Regulation in 1996:
- Incorporates ISO 13485:2016 by reference
- Manufacturers with a conforming ISO 13485:2016 QMS substantially satisfy the QMSR
- US-specific additions remain: DHF, MDR-integrated complaint handling, CAPA data requirements, distribution records
- Effective date: February 2, 2026
LDT oversight (ongoing phase-in)
FDA's Laboratory-Developed Test (LDT) Final Rule (May 2024) begins a 5-stage phase-in of FDA oversight over tests designed, manufactured, and used within a single laboratory. Previously FDA exercised enforcement discretion over LDTs. The phase-in runs from 2024 through 2029.