Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions

Update: August 7, 2024

The revised part 820 is now titled the Quality Management System Regulation (QMSR). When referring to the rule that is currently effective, the FDA uses the term "Quality System (QS) Regulation" or "QS regulation." Because both the QMSR and the QS regulation are located in part 820, wherever possible, the FDA has used the terms "QS regulation" and "QMSR."

On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.

This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The rule amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485. These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. This revised part 820 is referred to as the Quality Management System Regulation (QMSR). The FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.

This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

This section provides answers to frequently asked questions related to the final rule. These questions and answers provide clarity and do not introduce any new policies or modify any existing policies.

1. Why is the FDA taking this action?

The FDA is focused on advancing and continually improving the quality, safety, and effectiveness of medical devices to meet patient needs. This action harmonizes key areas of a device manufacturer’s Quality Management System and more closely aligns the United States with many other regulatory authorities around the world.

2. What is the FDA doing to prepare for harmonization of the Quality System regulation with ISO 13485?

The FDA intends to engage in a variety of implementation activities including updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection process, revising relevant regulations and other documents impacted by this rulemaking, and communicating and educating stakeholders, including affected FDA staff, on the change.

3. What training will FDA staff do?

FDA staff will be trained on the final rule, the revised inspection process and changes to associated policies and procedures. Additionally, the FDA will continue to conduct Quality Management System trainings within the FDA to familiarize staff with quality management system concepts and requirements.

4. How will this rule impact FDA staff and programs?

The FDA will continue to ensure the safety and effectiveness of medical devices including by conducting inspections, which will incorporate the requirements of the final rule on the effective date of the rule. The final rule will also impact the FDA’s internal trainings, which will familiarize staff with the new regulation. The FDA intends to update relevant procedures, processes, and policies to reflect the final rule.

5. Now that FDA has incorporated ISO 13485:2016, what happens if the standard is revised?

The FDA will evaluate any future revisions to this standard to determine the impact of any changes and whether the QMSR should be amended. If appropriate, amendments to the QMSR will be implemented through the rulemaking process.

6. When will the new regulation be effective?

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

7. Will FDA start enforcing the QMSR on February 2, 2026?

Yes, the QMSR final rule was published on February 2, 2024, with an effective date two years later, on February 2, 2026.

8. What records does the FDA intend to review during inspections conducted on or after February 2, 2026?

To help determine compliance with the QMSR, FDA investigators may review records that are part of the manufacturer’s QMS, including those created before February 2, 2026. As set forth in the preamble to the final rule, the requirements of the QS regulation and the QMSR are substantially similar. A manufacturer may find it useful to complete some type of comparative analysis to demonstrate documents and records created prior to the QMSR effective date meet the QMSR requirements.

9. On or after the QMSR effective date of February 2, 2026, does FDA intend to review records that were previously exempt from review under QS Regulation 820.180(c) (e.g. internal audits, supplier audits, and management review reports)?

Yes. The QMSR gives the FDA the authority to inspect management review, quality audits, and supplier audit reports. The exceptions that existed in the QS regulation at § 820.180(c) are not maintained in the QMSR. As set forth in the preamble to the final rule, since manufacturers are required to provide such documents to other regulators, they will not be additionally burdened by making these records available to FDA inspectors. Such records are maintained in the regular course of business and should be readily available upon inspection.

10. Will there be a new inspection process?

Yes, the FDA will have a new inspection process to align with the requirements of the Quality Management System Regulation (QMSR). On February 2, 2026, the Quality System Inspection Technique (QSIT) will be withdrawn, and the new inspection process will be implemented.

11. Where do I find information about the new inspection process for QMSR?

The QMSR inspection process will be documented in a revised version of the Compliance Program (CP), Inspection of Medical Device Manufacturers. The revised CP will be effective on February 2, 2026, and will be available on the FDA device CP webpage no later than the QMSR effective date. The device CPs are available here: Center for Devices and Radiological Health (CDRH) Compliance Programs | FDA.

12. How should a manufacturer prepare for an FDA device inspection that occurs on or after February 2, 2026?

The best way to prepare for an FDA inspection is to meet the FDA requirements that apply to your FDA regulated product. During an inspection on or after the QMSR effective date, FDA recommends that firms be prepared to discuss and provide records that demonstrate compliance with the QMSR requirements.

13. How does a medical device manufacturer obtain access to the two standards that have been incorporated by reference in the QMSR, namely, ISO 13485:2016 and ISO 9000:2015 Clause 3?

The standards can be accessed in a read-only format at the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal https://ibr.ansi.org/Standards/iso1.aspx. See Section III. Background G. Incorporation by Reference of the final rule.

14. How will FDA device inspections under the QMSR compare to Medical Device Single Audit Program (MDSAP) audits?

FDA inspections under the QMSR will not follow the MDSAP audit plan or procedures. The FDA will not require certificates of conformance to ISO 13485 and will not issue certificates of conformance to ISO 13485. A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection. See responses to public comments 79, 80, and 81 in the final rule. FDA inspections assess compliance to FDA regulations and are scheduled based on risk factors. Third-party audits assess conformance to a standard and occur annually based on a three-year plan.

MDSAP is a voluntary third-party audit program and will still be available to manufacturers who choose to participate.

Contact Us

For specific questions about the final rule, please email QMSR-Rule@fda.hhs.gov.

For general regulatory information, please contact the Division of Industry and Consumer Education (DICE) by phone at:(800) 638-2041 or (301) 796-7100 or by email at: DICE@fda.hhs.gov.