USA: FDA New Quality Management System Regulation

This blog was originally posted on 12th March, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY DENISE MCDERMOTT, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

On 2nd February 2024, the US Food and Drug Administration (FDA) published its Quality Management System Regulation (QMSR) final rule, amending the Code of Federal Regulations; 21 CFR Part 820, by incorporating by reference the quality management system requirements of the 2016 edition of ISO 13485. ISO 13485 specifies requirements for a quality management system for the medical device industry.

What’s New?

The overall scope of the FDA’s Quality System regulation (QSR) will remain the same, and in general, the requirements of ISO 13485:2016 were already similar to the requirements in the QSR.

However, some provisions of the QSR are amended and certain concepts of ISO 13485:2016 are clarified. The FDA has amended the title of the regulation and established some additional requirements, which include requirements for control of records, those relating to labeling and packaging, and those surrounding risk management, stating that they will add the requirement that “the organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained.”

Furthermore, the FDA has removed the exception in § 820.180(c) related to management review, quality audits, and supplier audit reports. Moreover, Clause 3 of ISO 9000:2015 is also incorporated by reference into the new rule and covers important and relevant terms and definitions. The FDA has also made ‘conforming edits’ to 21 CFR part 4 to clarify the quality management system requirements for combination products.

Overall, manufacturers need to meet the additional QMSR requirements as well as those in ISO 13485.

Future Changes

The FDA has stated that any future changes to ISO 13485 will still be evaluated and not automatically incorporated. Further work will be carried out by the FDA regarding IT system updates, training of staff, and any related revisions to other regulations or guidance documents. The FDA has stated that they will develop a new inspection process to align with the requirements of the new QMSR.

What’s Next?

The new rule will become effective on 2nd February 2026 so manufacturers have two years to make any necessary changes to align their internal procedures and update their documentation per QMSR requirements.

The new rule will promote consistency in the regulation of devices and allow for greater alignment with international requirements.

References:

USA: Quality System for Medical Device Manufacturing, 21 CFR Part 820 – Amendment – (on quality system regulation), Final Rule, 89 FR 7496, February 2024
USA: Quality System for Medical Device Manufacturing, Final Rule, 21 CFR Part 820, 2008
Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions

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