Regulatory glossary

21 CFR 820: What the QMSR Changed in February 2026

21 CFR Part 820 is the FDA regulation governing quality systems for medical devices. It still exists, but what it contains changed fundamentally on 2 February 2026.

Part 820 used to be the Quality System Regulation (QSR), spelling out requirements in FDA's own words across subparts covering design controls, document controls, purchasing, production, CAPA and records. It is now the Quality Management System Regulation (QMSR), and it incorporates ISO 13485:2016 by reference instead.

If a guide you are reading walks through Part 820 subpart by subpart with its own text for design controls and CAPA, it is describing the pre-2026 regulation. A great deal of published material still does.

What actually changed

The text moved. Part 820 is now much shorter. For most requirements it points you at the corresponding clause of ISO 13485:2016 rather than restating it. Compliance means meeting ISO 13485:2016 plus the FDA-specific requirements retained in Subparts A and B.

The terminology changed. Three acronyms every device company built its quality system around are no longer the regulation's language:

The obligations did not go away. You still have to hold controlled manufacturing specifications, still have to retain production history records, and still have to keep design and development records. What changed is the name and the clause you cite, not whether the record must exist.

Design controls were re-homed, not relaxed. The old §820.30 requirements map onto ISO 13485 clauses 7.3.1 through 7.3.9. Planning, inputs, outputs, review, verification, validation, transfer and changes are all still there.

What this means in practice

Your QMS documentation cites the wrong thing. SOPs, templates and training material that reference "§820.30 Design Controls" or "the DMR" are pointing at language the regulation no longer uses. The underlying process is usually fine; the citations are stale.

Already ISO 13485 certified? You are most of the way there. Companies selling into the EU have generally held ISO 13485 for years. The QMSR is close to the harmonisation those companies already achieved, with the FDA-specific additions on top. This is the point of the rule.

Certification is not compliance. An ISO 13485 certificate from a notified body is not an FDA finding. FDA inspects against the QMSR, including the FDA-specific requirements that are not in ISO 13485.

Inspections change shape. FDA's device inspection approach is being aligned to the new structure, so an investigator's questions follow ISO 13485 clauses rather than the old subparts.

What to do about it

1. Re-map your documentation. Produce a cross-reference from your existing procedures to ISO 13485 clauses and to the retained FDA sections. Most of the work is citation, not process.
2. Rename deliberately, or not at all. "DHF" is not forbidden, and many teams keep the term internally. What matters is that the file satisfies the design and development file requirement. Renaming everything at once creates traceability gaps for no regulatory benefit.
3. Check your supplier agreements. Quality agreements referencing Part 820 subparts by number may need updating to stay meaningful.
4. Do not assume your consultant's template is current. Material written before 2026 describes the QSR.