21 CFR Part 820 Compliance and the FDA QMSR

21 CFR Part 820 sets the quality system requirements for medical devices sold in the United States. Since 2 February 2026 it has been the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference. Medfins International helps manufacturers in India and worldwide close the gaps, prepare for FDA inspection and stay compliant.

What changed with the FDA QMSR?

• The former Quality System Regulation was replaced by the QMSR, which incorporates ISO 13485:2016 by reference rather than restating its requirements.
• FDA-specific requirements remain on top of ISO 13485, for example for complaint and record handling, labelling and packaging controls, and unique device identification.
• Records of management review, internal quality audits and supplier audits are no longer excluded from FDA inspection, so they must be inspection-ready.
• Terminology now follows ISO 13485, and FDA has retired its previous QSIT inspection approach in favour of a QMSR-based approach.

Who must comply with 21 CFR Part 820?

Finished device manufacturers selling in the United States, including foreign manufacturers, contract manufacturers and specification developers, must comply. Compliance is checked during FDA inspections and is a condition of keeping establishment registration and 510(k) clearances meaningful in practice.

Our 21 CFR Part 820 services

1. QMSR gap assessment of your ISO 13485 system against 21 CFR Part 820, with a prioritised action plan.
2. Procedure and record updates for complaint handling, design controls, purchasing, labelling, UDI and records.
3. Design history and device master record clean-up so they map to the ISO 13485 medical device file.
4. Mock FDA inspection by experienced auditors, including management review and supplier audit records.
5. Form 483 and warning letter responses with CAPA plans and evidence.
6. Process validation and ISO 14971 risk management files that hold up in inspection.

Common gaps we find in QMSR assessments

• Management review and internal audit records written on the assumption the FDA would never read them.
• Complaint files that do not show a documented decision on whether a complaint is reportable to the FDA.
• Supplier controls that rely on certificates instead of risk-based evaluation and monitoring.
• Design history files that cannot be traced to the medical device file required by ISO 13485.
• Labelling and UDI controls that are not covered by procedures or inspection records.

Each gap comes with a practical fix, an owner and evidence that will satisfy an investigator. For manufacturers in India, we combine the QMSR work with CDSCO and ISO 13485 so one audit-ready system serves every market.

QMSR and ISO 13485 together

Because the QMSR builds on ISO 13485:2016, one well-designed quality system can now serve the FDA, MDSAP, EU MDR and CDSCO. We design your system once and map it to each regulator, avoiding duplicate procedures. See our ISO 13485 certification service and our 21 CFR 820 case study.

Ready to start? Book a free consultation with Medfins International or call +91 85270 48221.

Frequently asked questions