FDA’s Revised QMSR Modernizes Device Quality Regulation

By Brynn Stanley

Background

On February 2, 2024, FDA published the final rule titled Medical Devices; Quality System Regulation Amendments to modernize 21 CFR Part 820 and bring U.S. device quality requirements into closer alignment with internationally recognized quality management system expectations. The final rule revised the title of Part 820 to the Quality Management System Regulation (QMSR) and established an effective date of February 2, 2026.

Historically, Part 820 codified the Quality System Regulation (QSR) and outlined current good manufacturing practice (CGMP) requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices. Under the revised framework, much of the substantive content of Part 820 is achieved through the incorporation by reference of ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. Where FDA identified topics not fully addressed by ISO 13485, the QMSR includes supplemental requirements to maintain public health protections:

• ISO 13485 Integration: Compliance with ISO 13485:2016 is now a regulatory expectation under Part 820. ISO 13485’s process-oriented, risk-based approach becomes the baseline for many quality system elements, including design and development controls, risk management, supplier controls, and corrective and preventive action.
• Part 820 Structure: The new QMSR retains only key structural sections of Part 820 (e.g., scope and definitions) while directing quality system requirements to ISO 13485 and related standards such as ISO 9000. Supplemental Part 820 requirements address areas not fully covered in the international standard.
• Inspection and Compliance: FDA simultaneously retired the longstanding Quality System Inspection Technique and published a revised compliance program manual (CP 7382.850). This updated inspection framework shifts from predefined subsystem sampling to a risk-based evaluation of the firm’s entire quality management system, consistent with international audit practices.

Inspection Emphasis and Operational Impacts

Under the new compliance program, investigators will select quality management system elements for review based on product-specific risks, complaint histories, prior compliance issues, and other risk indicators. This approach aligns more closely with ISO-style quality system auditing and emphasizes risk management documentation, internal audit records, supplier evaluation results, and management review findings.

Manufacturers should note that although FDA does not require third-party ISO 13485 certification, compliance with the standard’s requirements is expected in practice and will be evaluated during inspections.

“I view the transition to QMSR as an overdue and welcome modernization of FDA’s device quality framework. For years, global manufacturers have operated under ISO 13485 while maintaining a parallel U.S. compliance overlay. Harmonizing Part 820 with ISO 13485 brings clarity, consistency, and efficiency to multinational quality systems. It also signals FDA’s commitment to a more risk-based, globally aligned inspection approach. For manufacturers willing to invest thoughtfully in system integration and inspection readiness, this transition presents an opportunity to streamline compliance and strengthen overall quality culture.”
— Brynn Stanley, Associate Attorney

Key Points

• Effective February 2, 2026, the Food and Drug Administration’s revised QMSR replaces the legacy QSR and harmonizes 21 CFR Part 820 with international quality management system requirements. (U.S. Food and Drug Administration)
• The QMSR incorporates by reference ISO 13485:2016, making the global standard a regulatory foundation for device quality management systems in the United States. (U.S. Food and Drug Administration)
• In addition to harmonization, the final rule contains targeted supplemental requirements and conforming edits to ensure alignment with applicable FD&C Act requirements and U.S. regulatory expectations.
• FDA has transitioned to a risk-based inspection model under a new compliance program (Inspection of Medical Device Manufacturers Compliance Program 7382.850), retiring the Quality System Inspection Technique (QSIT) that guided inspections for decades.

Action Items for Manufacturers

• Gap Assessment: Conduct a comprehensive gap assessment of your existing quality management system against ISO 13485:2016 and the revised QMSR requirements.
• Document Updates: Revise standard operating procedures, work instructions, and quality policies to reference QMSR language and ISO 13485 clauses where applicable.
• Training: Educate quality, regulatory, engineering, and leadership teams on the QMSR expectations, new inspection approach, and risk-based compliance emphasis.
• Inspection Readiness: Prepare for FDA inspections under the new compliance program by ensuring key records such as internal audit results, management reviews, supplier audits, complaint investigations, and risk evaluations are inspection-ready.

How Gardner Law Can Help

The transition to QMSR marks a substantial regulatory evolution in U.S. medical device quality management expectations. By aligning the U.S. framework with ISO 13485 and adopting a risk-based inspection model, FDA aims to elevate quality system effectiveness, promote global harmonization, and better protect patient safety. Gardner Law regularly assists manufacturers in monitoring FDA communications, guidance updates, and implementation resources and in translating evolving QMSR expectations into practical, inspection-ready compliance strategies. Contact us to evaluate your quality system against QMSR and ISO 13485 requirements and prepare for FDA’s risk-based inspection approach.