FDA Medical Device Quality System Regulation (QSR) Amendment: Current Status and Industry Impact

Background and Initial Amendment Announcement

In 2018, the U.S. Food and Drug Administration (FDA) announced its intention to align the medical device quality system regulation codified in 21 CFR Part 820 (QSR: Quality System Regulations) with the international standard ISO 13485:2016. According to the initial timeline, the FDA planned to issue a Proposed Rule in spring 2019 and transition to a quality system regulation aligned with ISO 13485:2016 by 2020.

Regulatory Amendment Delays and Contributing Factors

The original timeline was significantly delayed due to the impact of the COVID-19 pandemic. As of September 2020, Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH), stated at a Regulatory Affairs Professional Society (RAPS) conference that the issuance of the Proposed Rule was anticipated to occur in October 2020.

During the conference, Director Shuren provided context for the delayed schedule, explaining that while QSR alignment with ISO 13485:2016 remained a high priority for CDRH, the agency’s focus on COVID-19 response necessitated reallocation of resources. As he stated: “The alignment of QSR with ISO 13485:2016 remains a high priority for CDRH. However, as you can imagine, due to our need to concentrate our efforts on the COVID-19 response, there are many other matters on which we have not been able to devote the same level of attention. Therefore, it is anticipated that it will take some additional time before we can issue an ISO 13485 regulation.”

Implementation Strategy and Transition Period

Regarding the implementation of the ISO 13485 regulation, the FDA indicated that it would provide a reasonable transition period for industry compliance. Director Shuren elaborated on the regulatory process: “With respect to implementation of the ISO 13485 regulation, we will provide a transition time. However, when we issue the proposed rule, we must obtain public comments, review those comments, and issue a final rule. Therefore, through the proposed rule, you will understand what FDA is planning. This should provide a starting point for people to begin implementing the appropriate changes.”

This incremental approach allows medical device manufacturers to use the Proposed Rule as a reference point for initiating necessary modifications to their quality systems in preparation for the final rule.

Recent Regulatory Developments

Subsequently, the FDA continued its amendment efforts, and on March 15, 2023, the FDA finally issued a Proposed Rule titled “Medical Device Quality System Regulation Alignment with ISO 13485:2016” in the Federal Register (88 FR 15630).

This Proposed Rule outlined the specific regulatory amendments necessary to align QSR with ISO 13485:2016. The major areas of amendment include design control, risk management, process validation, supplier management, and cybersecurity requirements. These changes reflect the FDA’s commitment to harmonizing U.S. regulations with internationally recognized quality standards.

Following issuance of the Proposed Rule, the FDA established a public comment period to solicit feedback from the medical device industry, regulatory professionals, and other stakeholders. This input is being incorporated into the development of the Final Rule, which will provide manufacturers with the authoritative requirements for compliance.

Industry Considerations and Preparatory Actions

As the QSR amendment progresses, medical device manufacturers should consider several key points. First, although many manufacturers may already comply with ISO 13485:2016, the new QSR requirements will create specific U.S. regulatory obligations that may differ from the international standard. Second, while a transition period is anticipated following Final Rule issuance, manufacturers must complete necessary quality system modifications within that timeframe. Third, manufacturers should thoroughly review the Proposed Rule, conduct a comprehensive assessment of their current quality systems against anticipated requirements, and develop implementation strategies in advance.

Proactive engagement with the Proposed Rule documents, regulatory guidance, and industry resources will enable manufacturers to minimize compliance disruptions and ensure timely readiness for the amended regulations.

Conclusion

The FDA QSR amendment represents a significant regulatory harmonization effort designed to align U.S. medical device regulations with international standards. Although the timeline experienced delays, the March 2023 issuance of the Proposed Rule marks a critical milestone in the regulatory revision process. Manufacturers must maintain vigilant monitoring of regulatory developments, carefully review the Proposed Rule and subsequent Final Rule guidance, and systematically prepare their quality systems to ensure full compliance when the amended regulations take effect.

References:

Federal Register: Medical Device Quality System Regulation Alignment with ISO 13485:2016 (88 FR 15630, March 15, 2023)
RAPS: CDRH Updates at Convergence: COVID-19 and ISO 13485 (September 2020)
FDA Center for Devices and Radiological Health (CDRH) official guidance documents and announcements