EU MDR · Expert · 13 min lesson
QMSR and FDA inspection readiness: what changed on 2 February 2026 and how inspections run
21 CFR part 820 (QMSR) sections 820.3, 820.7, 820.10, 820.35 and 820.45, ISO 13485:2016, FDA Compliance Program 7382.850
What you will learn
- Explain what the QMSR changed in 21 CFR part 820, with the publication and effective dates and the role of ISO 13485:2016.
- Describe how FDA inspects after 2 February 2026 and which records are now open to the investigator.
- Host an inspection, handle a Form FDA 483 and write a response that shows root cause and evidence.
Key takeaways
- The QMSR was published on 2 February 2024 (89 FR 7496) and took effect on 2 February 2026; it amends 21 CFR part 820.
- ISO 13485:2016 is incorporated by reference (section 820.7) and FDA adds sections 820.3(b), 820.10(b) and (c), 820.35 and 820.45.
- QSIT was replaced by Compliance Program 7382.850; inspections are risk based and a certificate gives no exemption.
- The former section 820.180(c) exception is not kept: management review, audit and supplier audit reports can be requested, including older ones.
- Prepare to host the inspection with named roles and a request log, and answer a Form FDA 483 in writing with root cause and evidence.
Free practice question
Norvane's quality manual says: 'Our ISO 13485 certificate from our certification body means FDA does not inspect us.' A new regulatory associate asks whether that is still true now that the QMSR is in force.
What is the correct position?
The statement is correct while the certificate is valid.
Not quite. FDA states that a certificate does not exempt a firm, and 21 CFR part 820 remains the standard of review.
The statement is wrong: a certificate gives no exemption, and inspections are risk-based under Compliance Program 7382.850.
Correct. This is FDA's stated position after the QMSR took effect on 2 February 2026, under 21 CFR part 820.
The statement is correct for class II devices only.
Not quite. Device class does not create an exemption; FDA inspects any registered manufacturer under 21 CFR part 820 and the Act.
The statement is wrong because FDA now audits only MDSAP members.
Not quite. MDSAP is voluntary, and FDA inspections do not follow its audit plan under the QMSR section 820.10 approach.
Key terms
- QMSR: The amended 21 CFR part 820, effective 2 February 2026, which incorporates ISO 13485:2016 and adds FDA-specific requirements.
- QSR: The former version of 21 CFR part 820 that applied until 1 February 2026.
- incorporation by reference: A legal technique by which a regulation makes a published standard part of its requirements (section 820.7).
- QSIT: Quality System Inspection Technique, FDA's former inspection guide, stopped on 2 February 2026.
- Compliance Program 7382.850: The FDA compliance program used to guide risk-based device quality inspections after 2 February 2026.
- Form FDA 483: The list of inspectional observations given to a firm at the end of an inspection; not a final agency finding.
- EIR: The investigator's written report of the inspection, on which FDA bases the classification.
- MDSAP: A voluntary single-audit programme for multiple regulators; FDA inspections do not follow its audit plan.
Official sources
- FDA - Quality Management System Regulation (QMSR) frequently asked questions
- Covington - FDA finalizes rule incorporating ISO 13485 into the QMSR (89 FR 7496)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.