What is the QMSR?
QMSR, or the Quality Management System Regulation, is a regulation (21 CFR Part 820) from the FDA that replaces FDA’s previous Quality System Regulation (QSR) for medical devices. It primarily incorporates by reference the international standard for medical device quality management systems, ISO 13485:2016. This aims to harmonize U.S. regulations with global standards and streamline compliance for medical device manufacturers.
What is different from ISO 13485?
While ISO 13485 forms the foundation of FDA’s requirements, the QMSR includes FDA-specific additions to maintain consistency with the Federal Food, Drug, and Cosmetic Act and other applicable U.S. regulations. For suppliers and manufacturers, this means that internal and supplier audits must demonstrate conformance to ISO 13485, along with any FDA-specific expectations. Some of the key aspects of the QMSR include:
- Incorporation of ISO 13485:2016 by reference: ISO 13485 comprises ~90% of the content of 21CFR820. While it does not require certification, you do need to be fully compliant to ISO requirements including Risk Management and Improvement.
- Terms: The QMSR contains modifications to definitions in ISO 13485 and ISO 9000 that supersede those standards, as well as additional definitions. These may require changes to an existing ISO 13485-certified QMS in order to comply as they modify ISO 13485.
- Records: The terms DMR, DHF, and DHR no longer exist in the QMSR in favor of ISO 13485 equivalent requirements. It’s expected that these legacy terms will continue to be used by many, but they will need to be defined in your QMS as they are not defined in the regulation.
- Exclusions during FDA inspections been removed: The FDA can now review your Internal and Supplier Audits and Management Review during inspections.
- Packaging and Labeling: 21 CFR 820.45 includes specific requirements not addressed in ISO 13485.
- Devices that support or sustain life: The QMSR expands the scope of the implantable device traceability requirements in ISO 13485.
References to Additional Regulations
Although the QMSR includes ISO 13485 as the primary framework, manufacturers must additionally comply with several key FDA-specific regulatory requirements that fall outside the scope of ISO 13485. These requirements are enforced under the Federal Food, Drug, and Cosmetic Act and related U.S. regulations. Key additional regulations include:
- Medical Device Reporting (MDR): Adverse event reporting requirements under 21 CFR Part 803 is referred to by the QMSR but only indirectly addressed by ISO 13485 (clause 8.2.3).
- Unique Device Identification (UDI): Requirements for labeling and device tracking under 21 CFR Part 830 are directly referred to in the QMSR.
- Establishment Registration & Device Listing: Facilities must register annually and list devices with the FDA under 21 CFR Part 807.
- Inspection Authority & Enforcement: The FDA retains full authority to conduct inspections and take enforcement actions. While the inspection approach will evolve, compliance with U.S. law—not just ISO 13485—remains the standard.
- Labeling Requirements: Certain device labeling requirements under 21 CFR Part 801 apply beyond what is required by ISO 13485.
- Postmarket Requirements: Responsibilities related to complaint handling, recalls, corrections, and removals are enforced under FDA regulations.
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What Should You Do?
Implementing the QMSR is not just a paperwork exercise — it’s a commitment to regulatory expectations and inspection readiness. Medical device manufacturers, contract manufacturers, and other economic operators (e.g., distributors, importers) are required to comply with the Quality Management System Regulation (QMSR). Organizations should treat this as both a compliance requirement and a strategic opportunity to modernize their quality systems. Key recommended actions include:
- Perform a Gap Assessment: Compare your current Quality Management System against ISO 13485:2016 requirements. Pay close attention to areas historically not emphasized under 21 CFR 820, such as risk management, validation of QMS software tools, and postmarket surveillance expectations. Companies experienced in ISO 13485 are likely fairly compliant with the QMSR but this will provide a fact-based assessment of where you stand. It is also the first step in developing a quality plan to update your QMS to be fully compliant with the QMSR. We can also provide consulting work to help you implement the necessary changes.
- Update Procedures and Documentation: Revise SOPs, work instructions, and templates to align with ISO 13485 structure and terminology as amended by 21 CFR 820. This may include renaming or restructuring elements previously tied to DMRs, DHFs, or DHRs.
- Train Internal Teams: Ensure quality and regulatory personnel understand ISO 13485 requirements and how they will be applied under the QMSR. This includes training on definitions, document expectations, and audit readiness.
- Prepare for New Inspection Criteria: Although FDA has shifted away from QSIT, inspections will still evaluate conformance to FDA-specific requirements. Internal and supplier audits, management review documentation, and quality records will likely be reviewed in detail.
- Monitor FDA Guidance: Stay current with updates from FDA on inspection procedures, guidance documents, and potential amendments related to the QMSR. This is especially important on and after 2026 since the QMSR has gone into effect.
- Plan Your Implementation Timeline: Set internal milestones for gap closure, training, and procedure updates to ensure you are fully prepared for both ISO 13485 certification audits and FDA inspections.
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