FDA QSR Harmonization with ISO 13485

Background and Objectives

In February 2018, the FDA announced its intention to harmonize the Quality System Regulations (QSR) for medical devices with ISO 13485. This initiative represents a strategic component of the international harmonization efforts for medical device quality management system regulations.

The primary objectives of this harmonization are to reduce the compliance burden and administrative procedures related to record-keeping requirements for medical device manufacturers, thereby facilitating the entry of more medical device companies into the U.S. market.

Mapping Efforts and Submission of Amendment Proposal

The FDA conducted comprehensive mapping activities to evaluate ISO 13485:2016 requirements and identify gaps between the current QSR and ISO 13485:2016 requirements. Through this systematic analysis, the FDA clarified the differences between QSR and ISO 13485:2016 provisions.

Subsequently, on January 5, 2021, the FDA submitted a proposed amendment to align QSR with ISO 13485:2016 to the OMB (White House Office of Management and Budget) for review.

OMB Review Process

The OMB serves as the agency responsible for reviewing proposed final rules from government agencies in accordance with Executive Order 12866. While OMB reviews typically require 90 days, the review of this particular proposal was completed in an expedited manner of 35 days. This swift review process suggests that the proposed amendment had received thorough prior consideration and underscores its significance as a regulatory foundation.

The proposed amendment successfully passed the OMB review and advanced to the next phase.

Planned Implementation Activities

The FDA plans to undertake multiple activities in accordance with the proposed amendment, including the revision of relevant regulatory documents and the implementation of educational programs for CDRH (Center for Devices and Radiological Health) staff. These preparatory activities represent crucial steps to facilitate the smooth transition of medical device manufacturers to the new regulations.

Additionally, a public comment period regarding the transition to the new regulations is scheduled to be conducted in the future, allowing for the incorporation of feedback from the medical device industry.

ISO 13485 Revision Trends and Challenges

Regarding ISO 13485, the revision cycle has progressed and ISO 13485:2023 has been released. Furthermore, it has been noted that ISO 13485:2016 is not fully aligned with ISO 9001:2015.

However, due to the implementation status of MDSAP (Medical Device Single Audit Program) and the ongoing progress of the FDA’s harmonization plan with ISO 13485, a cautious approach has been adopted concerning revisions to ISO 13485.

Implications for Medical Device Manufacturers

The progression of this regulatory harmonization has multiple implications for medical device manufacturers. First, the harmonization of FDA regulations with ISO 13485 requirements may facilitate simultaneous compliance with both sets of requirements. Second, particularly for medical device manufacturers with global expansion strategies, improved efficiency in managing compliance with multiple regulatory systems is anticipated.

Conversely, manufacturers are advised to carefully examine the details of the proposed amendment when it is made public and to identify discrepancies with their existing quality management systems at an early stage.

Conclusion

The OMB approval of the FDA’s QSR amendment proposal represents an important milestone in the progression of international regulatory harmonization. Close attention to industry developments during the public comment period and the final publication of the regulations will be essential going forward.