🚨 Breaking: The FDA Issues its QMSR Final Rule
The FDA's final rule amending the Quality System Regulation is finally here. We quickly break down the changes made from the proposed rule.
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This morning, the FDA issued the following bulletin:
FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation
To ensure medical devices on the market are safe, effective, and of good quality, the U.S. Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) Final Rule.
The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
The rule amends the current good manufacturing practice requirements of the Quality System regulation in 21 CFR 820.
“This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “By harmonizing key areas of a medical device manufacturer’s quality management system with the international standard, the FDA is streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation.
If you have questions about this final rule, contact the Division of Industry and Consumer Education.
A brief comparison between the proposed and final rules
Overall, the final rule largely aligns with the proposed rule, with adjustments made for clarity, compliance with international standards, and responses to comments received. The core aspects of the proposed rule, such as the incorporation of ISO 13485, remain intact.
Here's a more detailed comparison—at a glance:
Scope and Applicability:
Proposed Rule: Focused on combination products' compliance with CGMP requirements, providing options for streamlined compliance.
Final Rule: Maintained the focus on finished devices, specifying that these provisions apply to any finished device manufactured or imported into the U.S. The exemptions for certain manufacturers, such as those of blood components, remained consistent.
Incorporation by Reference:
Proposed Rule: Incorporated ISO 13485, suggesting specific clauses for compliance alongside part 820.
Final Rule: Continued incorporation of ISO 13485, but clarified how definitions in ISO 13485 should be interpreted in different jurisdictions.
Definitions and Clarifications:
Proposed Rule: Proposed changes to terms for alignment with ISO 13485, like redefining 'management with executive responsibility' to 'top management'.
Final Rule: Incorporated the entire introduction of ISO 13485 and retained the proposed changes in definitions, responding to comments for better clarity.
Quality Management System Requirements:
Proposed Rule: Emphasized the need for a quality management system, encouraging manufacturers of components or parts to consider these regulations.
Final Rule: Similar emphasis on quality management systems, ensuring suitability for the specific devices.
Specific Provisions for Combination Products:
Proposed Rule: Detailed requirements for combination products, specifying compliance with certain ISO 13485 clauses in addition to part 820.
Final Rule: Made slight modifications to these requirements, reflecting feedback received during the comment period.
Effective Date and Implementation Strategy:
Proposed Rule: Opened for comments on the effective date and implementation strategy.
Final Rule: Set a specific effective date and detailed an implementation strategy, incorporating the feedback from the comment period.
Economic and Environmental Impact Analysis:
Proposed Rule: Presented a preliminary analysis of economic impacts and environmental considerations.
Final Rule: Offered a more comprehensive analysis, enriched by comments and further research.
Comments and Responses Section (Exclusive to Final Rule):
Final Rule: Included responses to comments received on the proposed rule, providing clarification and justifications for the changes made.
Stay tuned—we will be conducting a more thorough and deep analysis of the final rule.
Talk to us about scheduling your gap assessment
The QMSR introduces a new framework for the medical device QSR, which the industry has been waiting for. Firms will have two years to become compliant.
Demand for excellent ISO 13485:2016/QSR consultants is already extremely high. If you need compliance assistance, get in touch with us to learn more and start the conversation.
We’ve helped firms assess against both of these ISO standards and, when desired, plan and help execute the necessary quality system remediation and training on the other side of the assessment.
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