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21 CFR Part 820 · FDA QMSR · ISO 13485:2016

QMSR Transition for Medical Devices: From QSR to 21 CFR 820 QMSR

The FDA's Quality Management System Regulation replaced the old QSR on 2 February 2026. We help US and foreign device manufacturers align their QMS with ISO 13485 and the new 21 CFR 820, update records and labelling controls, and prepare for QMSR-based FDA inspections.

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2 Feb 2026QMSR effective date
ISO 13485incorporated by reference
US & foreignmanufacturers covered
The basics

What is the FDA QMSR?

The Quality Management System Regulation (QMSR) is the new 21 CFR Part 820. Instead of FDA's own quality system requirements, it incorporates ISO 13485:2016 by reference and adds a small set of FDA-specific requirements.

For manufacturers that already run an ISO 13485 system, the change is mostly about re-mapping documents and closing FDA-specific gaps. For those built only on the old QSR, it means a structured move to ISO 13485 terminology and processes.

ISO 13485 at the coreClauses 4 to 8 now form the basis of FDA compliance.
FDA-specific additionsRecords, labelling and packaging controls, and FDA definitions.
More open to inspectionManagement review and internal audit records can now be reviewed.
What changed

QSR vs QMSR: what changed on 2 February 2026

The main differences your QMS needs to reflect.

TopicOld QSRQMSR
BasisFDA’s own quality system requirementsISO 13485:2016 incorporated by reference, plus FDA additions
Design & production filesDesign History File, Device Master Record, Device History RecordISO 13485 medical device file, design and development file and production records
Risk managementMainly in design validationRisk-based approach across all QMS processes
Management review & auditsReports excluded from FDA inspectionReports open to FDA inspection
Labelling & packagingSections 820.120 and 820.130Retained as section 820.45
RecordsSections 820.180 to 820.198Section 820.35 adds FDA record needs, including complaints, servicing and UDI
Inspection approachQSIT-based inspectionsNew QMSR-based inspection approach
How it works

How we manage your QMSR transition

A practical route from QSR-based procedures to a QMS that is ready for a QMSR inspection.

  1. 1

    Gap assessment

    QSR → QMSR

    We map your current procedures against ISO 13485 clauses and the FDA-specific QMSR requirements.

  2. 2

    Re-map documents

    DHF · DMR · DHR

    We align file names, structure and references with ISO 13485 terminology.

  3. 3

    Update procedures

    Risk-based

    We revise procedures to build a risk-based approach into every QMS process.

  4. 4

    Records, labelling & packaging

    820.35 · 820.45

    We close gaps in complaint, servicing and UDI records and in labelling controls.

  5. 5

    Train your team

    Roll-out

    We train staff on what changed and what FDA investigators will now ask for.

  6. 6

    Mock FDA inspection

    Readiness

    We run a QMSR-based mock inspection, including management review and audit records.

  7. 7

    Ongoing support

    483 responses

    We support real inspections and help answer any Form 483 observations.

Avoid observations

Common QMSR transition gaps

01
QSR wording left in placeProcedures still refer to DHF, DMR and DHR with no mapping.
02
Risk only in designNo risk-based approach in purchasing, production or CAPA.
03
Audit records not readyManagement review and internal audit reports not fit for FDA review.
04
Record gapsComplaint, servicing and UDI records missing FDA-specific content.
05
Software not validatedQMS software tools not validated for intended use.
06
Untrained staffTeams unsure how to answer QMSR-based inspection questions.
Our service

Our QMSR transition services

QMSR gap assessmentClause-by-clause against ISO 13485 and FDA additions.
Procedure updatesRe-written procedures and document mapping.
Records & labelling controlsSections 820.35 and 820.45 brought into line.
TrainingQMSR awareness for management and staff.
Mock FDA inspectionsQMSR-based readiness audits.
Form 483 responsesClear, timely responses to observations.

Related quality system services

Medical Device QMS Consultants ISO 13485 Certification Process MDSAP Certification Process GMP Consultants US FDA Consultants FDA Registration & Listing
FAQ

QMSR transition FAQs

When did the FDA QMSR take effect?

The Quality Management System Regulation took effect on 2 February 2026, two years after the final rule was published. From that date, FDA inspects device manufacturers against the QMSR rather than the old Quality System Regulation.

Do I need ISO 13485 certification to comply with the QMSR?

No. The QMSR incorporates ISO 13485:2016 by reference, but FDA does not require a certificate, and holding one does not exempt you from FDA inspections. What matters is that your QMS meets ISO 13485 and the extra FDA requirements.

What happened to the DHF, DMR and DHR?

The QMSR drops these QSR-specific terms. Equivalent content now sits in the ISO 13485 medical device file, design and development file and production records, so many manufacturers simply rename and re-map their existing documents.

Can FDA now review management review and internal audit reports?

Yes. Under the old QSR these reports were excluded from FDA inspection. The QMSR removes that exclusion, so management review, internal audit and supplier audit records can be inspected.

Does the QMSR apply to foreign manufacturers?

Yes. It applies to manufacturers of finished devices sold in the United States, wherever they are located, unless a device is specifically exempt from the quality system requirements.

Does MDSAP help with QMSR compliance?

Yes. MDSAP audits include FDA requirements, and FDA accepts MDSAP audit reports in place of routine inspections. A QMS ready for MDSAP is well placed for the QMSR.

Is your QMS ready for a QMSR inspection?

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