FDA Proposes Amendment to QSR to Harmonize with ISO 13485

Announcement of the Proposed Amendment and Background

On February 23, 2022, the FDA published a proposed amendment to the “QSR (Quality System Regulation)” for medical devices, aimed at harmonizing it with the international standard ISO 13485:2016. This proposal attracted significant attention from the industry as a major overhaul of the QSR.

Since its implementation in 1997, when the QSR replaced the previous medical device GMP regulations, only minor amendments such as the addition of UDI (Unique Device Identification) requirements had been made over the course of 25 years. The publication of this comprehensive proposed amendment marked a significant milestone, signaling the FDA’s commitment to modernizing quality system requirements for medical devices.

Purpose and Significance of the Amendment

The FDA has outlined several key objectives for the proposed QSR amendment.

First, there is the goal of international regulatory harmonization. ISO 13485 has been adopted by many countries and regions worldwide, and harmonizing the QSR with ISO 13485 is intended to reduce the regulatory compliance burden on medical device manufacturers seeking to market their products globally, particularly in the United States.

Second, the amendment aims at clarifying and updating the regulatory framework. The medical device industry has undergone substantial changes over the past 25 years, with the emergence of new technology domains such as software, artificial intelligence (AI), digital health, and cybersecurity. The proposed amendment seeks to provide a flexible regulatory framework capable of accommodating these emerging technologies.

Additionally, improving predictability for manufacturers is another significant objective. By aligning with ISO 13485, the requirements based on international best practices are clearly articulated, enabling manufacturers to establish quality management systems more efficiently.

Content of the Proposed Amendment and Regulatory Procedures

The proposed QSR amendment demonstrates how each chapter of ISO 13485 maps to the current subparts of the QSR (Subpart A, B, C, D, E, etc.). When the requirements of the proposed amendment and ISO 13485 do not fully align, the FDA identifies these differences and provides references to the relevant subparts that address FDA-specific regulatory requirements. This approach allows QSR users to understand ISO 13485 requirements while remaining aware of FDA-specific mandates.

The FDA will subsequently establish a public comment period to solicit opinions from stakeholders, including medical device manufacturers, patient advocacy groups, and subject matter experts. Following procedures required by law and after analyzing public comments, the FDA will publish the final rule, preamble (Preamble: responses to public comments and detailed explanation of regulatory rationale), and the effective date.

Planned Implementation Timeline

At the time of announcing the proposed amendment, the FDA envisioned implementation one year after the publication of the final rule. However, given the substantial impact that QSR amendments will have on the entire medical device industry, the effective date is subject to change during the process leading to the publication of the final rule.

As of January 2025, the progress from the publication of the proposed amendment in 2022 has not yet reached the stage of final rule publication. After the closure of the public comment period, the FDA has devoted considerable time to analyzing and responding to public comments, and work continues toward the preparation of the final regulatory document.

Mapping Table and Relationship with ISO 13485

The proposed amendment delineates the correspondence between the chapter structure of ISO 13485:2016 and FDA’s QSR as follows.

ISO 13485 Chapter	Item	Corresponding QSR Subpart	Primary Content
4	Organizational Context	A, B	Quality Management System, Responsibility, Resources
5	Leadership	A, B	Management Leadership, Customer Focus
6	Planning	C	Risk Management, Quality Objectives, Change Control
7	Support	D, E	Document Control, Competence Assurance, Monitoring and Measurement
8	Operation	E, F	Manufacturing, Inspection, Distribution Management
9	Performance Evaluation	G	Internal Audit, Complaint Handling
10	Improvement	C, G	Corrective Actions, Preventive Actions

This table illustrates the basic mapping structure outlined in the proposed amendment. For detailed information, reference should be made to the original text of the FDA’s proposed amendment.

Industry Impact and Future Preparedness

Once the QSR amendment is finalized, manufacturers seeking to market medical devices in the United States will be required to comply with the new QSR requirements. While many manufacturers have already obtained ISO 13485 certification, the difficulty of developing detailed compliance plans persists until the specific requirements of the new QSR are determined.

Medical device manufacturers and related stakeholders must continuously monitor the latest information released by the FDA and, upon publication of the final rule, promptly analyze the requirements and evaluate their company’s quality system for compliance. In particular, manufacturers operating in emerging technology domains such as software, AI and machine learning, and digital health should pay close attention to clarifications regarding regulatory requirements in these areas.

References

• FDA “Quality System (QS) Regulation/Medical Device Good Manufacturing Practices” https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
• FDA Frequently Asked Questions on the QSR Proposed Amendment https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions
• RAPS Article “QSR/QSMR: FDA Proposes QSR Overhaul After Years of Delay” https://www.raps.org/news-and-articles/news-articles/2022/2/qsmr-fda-proposes-qsr-overhaul-after-years-of-dela
• ISO 13485:2016 “Medical devices – Quality management systems – Requirements with regulatory focus”