February 6, 2024
New quality management system regulation rule harmonizes US regulations with international standard, reducing regulatory burden for device manufacturers
On Jan. 31, the Food and Drug Administration issued the Quality Management System Regulation Final Rule to support global harmonization in medical device regulation in an effort to provide effective, safe, and high-quality medical devices for patients. The rule was published on Feb. 2.
The announcement finalizes FDA's proposed rule to amend the current good manufacturing practice (cGMP) requirements for medical devices under the Quality System (QS) regulation, in 21 CFR 820, to harmonize with ISO 13485:2016 Medical devices — Quality management systems — Requirements (ISO 13485) for regulatory purposes, the international consensus standard for medical devices.
Specifically, the final rule amends the title and incorporates the quality management system requirements for medical devices established by ISO 13485, creating a new regulation: the Quality Management System Regulation (QMSR).
What does this mean for medical device manufacturers?
FDA's alignment of a medical device manufacturer's quality management system with the international standard should:
- Streamline regulatory processes for manufacturers to meet requirements by multiple regulatory authorities
- Increase efficiencies for manufacturers already in compliance with the ISO standard
However, because ISO 13485 requires application of a risk-based approach in establishing and maintaining all aspects of a quality management system (QMS), the final rule is expected to have an impact on risk management practices for medical device manufacturers. In addition, FDA has stated in its FAQs that it will develop a new inspection process to align with the requirements of the new QMSR, which will affect manufacturers once inspections under the new regulation begin.
FDA has also edited part 4 (21 CFR part 4) to clarify the device QMS requirements for combination products.
The rule will be effective Feb. 2, 2026, allowing device manufacturers and importers two years to assess their current systems, processes, and procedures and implement any necessary changes to meet the requirements of the QMSR rule. Manufacturers are required to comply with the existing Quality System regulation until the new rule takes effect.
What Can We Help You Solve?
Exponent's multidisciplinary team of medical device consultants can help manufacturers understand FDA's QMSR to support gap analyses and strategic planning. Knowledgeable in quality management systems and regulatory requirements, our experts provide wide-ranging technical services — including mechanical, chemical, and human factors studies — and analyses related to post market surveillance and device performance.