Two-minute brief
FDA QMSR (21 CFR Part 820) requirements explained: video brief
A two-minute brief on how the FDA's Quality Management System Regulation is structured and where its substance now sits.
Key takeaways
- Part 820 subpart A incorporates ISO 13485:2016 by reference.
- Subpart B adds FDA provisions on records, labelling and packaging.
- US law prevails where it conflicts with ISO 13485.
- Design controls, complaint handling and CAPA come through ISO 13485.
- The FDA inspects; it does not certify.
A short regulation with ISO 13485 inside it
Part 820 is now short. Subpart A holds the scope, the definitions, the incorporation by reference and the core duty to document a quality management system meeting the applicable requirements of ISO 13485 and Part 820. Subpart B adds the FDA's own provisions on records and on labelling and packaging, and the remaining sections are reserved. The substance therefore sits in ISO 13485 clauses 4 to 8, read with the FDA's definitions and cross-references. This short film shows that structure.
The scope section applies current good manufacturing practice to the design, manufacture, packaging, labelling, storage, installation and servicing of finished devices for human use made in or imported into the United States, for the operations a manufacturer performs. Where ISO 13485 clauses conflict with the Federal Food, Drug, and Cosmetic Act or FDA regulations, the US law prevails.
What the ISO 13485 clauses bring
Through incorporation by reference, the QMSR brings in the ISO 13485 requirements for the quality management system and its documentation, management responsibility, resource management, product realisation, including design controls, purchasing, production and process controls, and measurement, analysis and improvement, including complaint handling and corrective and preventive action. The FDA's own provisions add requirements for records, such as complaint and servicing records and unique device identification, and for the control of labelling and packaging.
The regulation applies to manufacturers of finished devices made in or imported into the United States, wherever located, including contract manufacturers, sterilisers, relabellers and specification developers. The amended Part 820 has been in force since 2 February 2026. The FDA inspects rather than certifies, and an ISO 13485 certificate does not exempt a manufacturer from inspection.
The FDA has stated that compliance with ISO 13485 alone does not fully satisfy the QMSR, while QMSR compliance is expected largely to satisfy ISO 13485; the gap is the FDA's own provisions, such as unique device identification, tracking and adverse event reporting. The exception that kept management review and internal audit reports from investigators is not carried into the QMSR, so those reports can now be inspected. Inspections follow a risk-based compliance programme that replaced the Quality System Inspection Technique.
FDA QMSR (21 CFR 820) at a glance
- Purpose
- Current good manufacturing practice for medical devices: the quality management system behind every finished device for human use sold in the United States
- Relevant to
- Manufacturers of finished devices made in or imported into the United States, wherever located, including contract manufacturers, sterilisers, relabellers and specification developers
- Edition
- 21 CFR Part 820 as amended by the final rule of 2 February 2024, in force since 2 February 2026, with ISO 13485:2016 incorporated by reference
- Certification
- None issued by FDA. The FDA inspects; it neither requires nor issues ISO 13485 certificates, and one does not exempt you from inspection
- Sterling's role
- Gap analysis against Part 820 and ISO 13485, implementation, Effivity, training, internal audit, mock inspection and inspection support, then Sustain™
- Cost and timing
- Total investment for an FDA QMSR-compliant quality management system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 3 to 12 months
FDA QMSR (21 CFR 820): questions people ask
Is there an FDA QMSR certificate?
No. The FDA assesses QMSR compliance by inspection. It has said it will not require certificates of conformance to ISO 13485, will not issue them, and that such a certificate does not exempt a manufacturer from an FDA inspection. An ISO 13485 certificate from an accredited body may still matter to customers and other regulators.
Our ISO 13485 certificate is current. Do we already comply with the QMSR?
Not on its own. The FDA has stated that compliance only with ISO 13485 does not fully satisfy the QMSR, while it expects compliance with the QMSR to largely satisfy ISO 13485. The gap is the FDA's own provisions: its definitions, UDI under Part 830, tracking under Part 821, adverse event reporting under Part 803, advisory notices under Part 806, the complaint and servicing record content of § 820.35 and the labelling and packaging controls of § 820.45.
When did the QMSR take effect, and is any transition left?
The final rule was published on 2 February 2024 and took effect on 2 February 2026. No transition remains: the FDA inspects against the QMSR now, and investigators may review QMS records created before 2 February 2026.
What replaced QSIT, and how does the FDA inspect now?
The FDA withdrew the Quality System Inspection Technique on 2 February 2026 and inspects under Compliance Program 7382.850, Inspection of Medical Device Manufacturers. It is risk-based: investigators weigh product risks to patients and users throughout, review your risk management documentation, and cover six QMS areas (management oversight; design and development; change control; outsourcing and purchasing; production and service provision; measurement, analysis and improvement) and four other applicable FDA requirements: medical device reporting, reports of corrections and removals, device tracking and unique device identification.
Can the FDA now read our management review and internal audit reports?
Yes. The QS regulation's exception at § 820.180(c) is not kept in the QMSR, so the FDA has the authority to inspect management review, quality audit and supplier audit reports.
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The complete guide
Everything on FDA QMSR (21 CFR 820)
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On the FDA QMSR (21 CFR 820) page
- What are the main FDA QMSR requirements?
- How do you become FDA QMSR compliant?
- How much does FDA QMSR compliance cost?
- How long does FDA QMSR compliance take?
- Who needs to comply with the FDA QMSR?
- How FDA QMSR compliance supports US market access and patient safety
- Frequently asked questions about the FDA QMSR
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