QMSR: Harmonizing US FDA QSR with ISO 13485:2016 – Key Insights for Manufacturers
In recent years, the U.S. FDA has made significant progress in aligning its regulatory framework with global standards, particularly within the medical device sector. A key development in this effort is the FDA’s move to harmonize the Quality System Regulation (QSR) with the ISO 13485:2016 standard. This initiative began in 2018, when the FDA announced its intention to base its quality system regulations on ISO 13485. The result is the introduction of the FDA Quality Management System Regulation (QMSR), which aims to streamline the regulatory process, facilitate broader global market access for U.S. manufacturers, and improve the safety and effectiveness of medical devices.
The Purpose Behind the Harmonization
On January 31, 2024, FDA released its Final Rule for the new Quality Management System Regulation (QMSR). The purpose of this harmonization is to ensure that medical device manufacturers in the U.S. adhere to internationally recognized quality management practices, facilitating smoother market access, improving product quality, and reducing regulatory burden across different regions.
ISO 13485:2016, the internationally recognized standard for quality management systems (QMS) in medical devices, has been widely adopted around the globe. The FDA’s QMSR initiative seeks to create alignment between the U.S. system and this global standard, enhancing consistency and reducing duplication in regulatory requirements, especially for manufacturers who wish to market their products both in the U.S. and internationally.
How QMSR is Different From QSR?
The FDA is integrating ISO 13485 into the current Quality System Regulation (QSR) by referencing specific sections of the ISO 13485:2016 standard, which will lead to notable changes in 21 CFR Part 820. While this adjustment brings modifications, many of these are simply semantic, and they won't alter the core quality management system (QMS) requirements for medical device manufacturers.
For instance, terms (but not the documentation requirements) like device master record (DMR), design history file (DHF), and device history record (DHR) are no longer present in the final rule. The FDA believes these concepts are sufficiently covered by ISO 13485 and will now be included under the umbrella term Medical Device File (MDF).
Additionally, the Final Rule introduces several new sections within Part 820, including:
Section 820.7 - Incorporation by reference
Section 820.10 - Requirements for a quality management system
Section 820.35 - Control of records
Section 820.45 - Device labeling and packaging controls (This is in addition to the requirements of 21 CFR Part 801)
To provide a clearer picture, below is the table of contents from the QMSR Final Rule:
What It Means for Manufacturers
The FDA's integration of ISO 13485:2016 into its Quality Management System Regulation (QMSR) brings significant changes for medical device manufacturers, with wide-reaching effects:
Simplified Compliance: Manufacturers already following ISO 13485:2016 will find aligning with QMSR easier, allowing them to use their existing QMS for FDA compliance, reducing the need for separate systems.
Enhanced Global Competitiveness: Aligning with QMSR allows easier access to global markets, as manufacturers will meet both FDA and international standards, facilitating entry into markets like the EU, Canada, and Japan.
Streamlined Audits and Inspections: While ISO 13485 certification does not automatically mean compliance with QMSR, aligning with ISO 13485 will reduce redundant audits. However, having ISO 13485:2016 certification does not automatically ensure compliance with the new QMSR. ISO-certified manufacturers are still subject to FDA inspections and will not receive an ISO 13485 certification of conformance post-inspection. While ISO 13485 compliance helps meet both U.S. and international standards, manufacturers must still adhere to all applicable FDA regulations and inspections.
Focus on Continuous Improvement: The harmonization emphasizes continuous improvement in quality systems. Manufacturers must proactively enhance their processes and products to meet regulatory standards and customer expectations.
Amendment to 21 CFR 4: The FDA has also amended 21 CFR Part 4 to improve the regulatory framework for combination products, aligning with ISO 13485 to reduce complexity for manufacturers.
“Aligning with global standards is not just about meeting regulations—it’s about elevating quality, enhancing competitiveness, and ensuring the safety and effectiveness of the devices that impact lives.”
The harmonization of QSR with ISO 13485:2016 through the introduction of the QMSR is a significant step towards simplifying the regulatory landscape for medical device manufacturers. This move aligns the U.S. FDA’s expectations with global quality management practices, creating efficiencies, improving product quality, and providing better market access.
For manufacturers, this presents an opportunity to streamline compliance, ensure better safety standards, and expand globally with greater ease. Understanding and adapting to these changes will position manufacturers for long-term success in an increasingly competitive and regulated market.
Need Help Navigating These Changes?
At Gladiolus Quality & Regulatory Services, we specialize in helping medical device manufacturers navigate the complexities of regulatory compliance. Whether you're preparing for QMSR implementation, adjusting your QMS, or seeking guidance on aligning with ISO 13485:2016, our team is here to guide you through every step of the process.
Don’t risk falling behind—reach out today, and let us help you stay ahead of the regulatory curve. We’re here to ensure your business is fully prepared for the FDA’s new Quality Management System Regulation and ready to thrive in the global marketplace.
