What it is and what has changed
Title 21 of the Code of Federal Regulations holds FDA’s binding rules. The four parts in this row are the core for drug and device quality:
- Part 11: electronic records and electronic signatures.
- Parts 210 and 211: current good manufacturing practice for finished pharmaceuticals.
- Part 820: the device quality system, now the Quality Management System Regulation (QMSR).
The biggest recent change is Part 820. The QMSR became effective on February 2, 2026, replacing the Quality System Regulation. It incorporates ISO 13485:2016 by reference, plus clause 3 of ISO 9000:2015 for definitions, and makes risk management an explicit requirement. Where ISO 13485 conflicts with the FD&C Act or FDA rules, FDA’s requirements control. On the same date FDA began using its new inspection compliance program (7382.850) and retired QSIT.
For AI tools, this means any Part 820 text indexed before February 2026 is now the old rule.
Where to find it
- eCFR (ecfr.gov): a continuously updated online version of the CFR. It lets you view the regulations as they stood on any date back to January 2017, compare two dates, see a change timeline, and subscribe to changes.
- Annual CFR edition (govinfo): the official print-equivalent edition, revised once a year for Title 21.
- Federal Register: the source of each amendment, with its effective date.
One point that matters for compliance: the eCFR states that it “is not an official legal edition of the CFR.” It is very convenient, but for legal citation the official edition and the Federal Register are the references.
Reuse terms
The text of federal regulations is a US government work and is generally free to reuse. The conditions are about version control, not copyright:
- Know which text you have: eCFR as of a date, or an annual edition.
- Track amendments and effective dates, which can differ from publication dates.
- Incorporated standards are separate. The QMSR incorporates ISO 13485:2016 by reference, but the ISO text itself is copyrighted and is not reproduced in the CFR. See the ISO article in this series.
Using the CFR in AI and RAG
- Pull text from eCFR with an “as of” date and store that date on every chunk.
- Keep the prior Part 820 (QSR) in an archive index, labeled “superseded February 2, 2026,” for questions about older records.
- Chunk by section (for example, 211.192) so citations stay exact.
- Link each section to its guidance, such as the 2024 Part 11 Q&A, and label which layer is binding.
- Subscribe to eCFR changes for Parts 11, 210, 211, and 820 and re-index when they change.
- Do not paste ISO 13485 text into the index just because the QMSR references it, unless your license allows it.
Common mistakes
- Citing eCFR as if it were the official legal edition.
- Leaving QSR-era Part 820 text in a live index after February 2, 2026.
- Treating publication date as effective date.
- Assuming “incorporated by reference” makes the ISO standard free to copy.
Checklist
- Text pulled from eCFR with an “as of” date
- Superseded QSR text archived and labeled
- Chunked by section with exact citations
- Change subscription set for each part
- Related guidance linked and labeled nonbinding
- ISO text excluded unless licensed
How AskDona helps
AskDona maps your quality manual and procedures to the current Part 820 and Part 211 sections and shows the regulation text, with its date, beside each match or gap. That makes a QSR-to-QMSR transition review easy to evidence.
AskDona shows the evidence; your quality team decides.
Editor’s note. This article is general information, not legal advice. The “conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is the eCFR the official CFR? No. The eCFR says it is not an official legal edition. Use the official annual edition and the Federal Register for legal citation.
When did the QMSR take effect? February 2, 2026.
Does the QMSR let me use ISO 13485 text freely? No. It incorporates the standard by reference, but the standard remains copyrighted by ISO.
How far back can I see older versions? The eCFR point-in-time view goes back to January 2017.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| eCFR: Getting Started | Continuously updated; not an official legal edition; point-in-time back to Jan 2017; compare and subscribe |
| FDA: Quality Management System Regulation (QMSR) | QMSR effective Feb 2, 2026; ISO 13485:2016 incorporated; inspection program 7382.850 |
| Cooley: FDA Finalizes Part 11 Guidance (Oct 24, 2024) | Part 11 guidance linked to the regulation |