FDA Releases Draft Guidance on Quality Management System (QMS) Requirements for Premarket Submissions — October 2025

In a major step toward global regulatory harmonization, the U.S. Food and Drug Administration (FDA) has released a new Draft Guidance for Industry and FDA Staff titled “Quality Management System Information for Certain Premarket Submission Reviews.”

This draft guidance, issued in October 2025, is a key milestone in aligning the FDA’s Quality Management System Regulation (QMSR) with the international quality standard ISO 13485:2016. Once finalized, it will officially replace the existing Quality System Regulation (21 CFR Part 820) on February 2, 2026.

Understanding the New FDA Draft Guidance

The new QMSR framework aims to ensure that medical device manufacturers adopt globally recognized best practices for quality management. It redefines how companies demonstrate compliance during Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) submissions.

By referencing ISO 13485:2016, the FDA seeks to reduce redundancy, improve consistency in audits, and streamline regulatory submissions for manufacturers operating in multiple jurisdictions.

Key Highlights of the Draft Guidance

1. Comprehensive QMS Documentation:

The guidance provides clear expectations for what QMS documentation should be included in PMA and HDE submissions, ensuring manufacturers establish transparent and verifiable quality processes.

2. Risk-Based Approach:

It emphasizes the importance of risk-based decision-making in designing, implementing, and maintaining a robust QMS — allowing manufacturers to prioritize actions that have the greatest impact on patient safety and product quality.

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3. Global Harmonization:

By harmonizing the FDA’s QMSR with ISO 13485:2016, this change reduces the regulatory burden for multinational manufacturers and supports regulatory convergence across markets.

4. Expanded Provisions:

The guidance introduces updated provisions under 21 CFR 820.10, 820.35, and 820.45, focusing on:

• Record control and traceability
• Labeling and packaging requirements
• Ongoing product improvement and management oversight

5. Continuous Improvement:

The FDA reinforces the need for continuous evaluation and enhancement of quality systems — ensuring medical devices meet evolving safety, performance, and regulatory standards.

Comment Period and Industry Participation

The FDA has opened a 60-day public comment period, inviting stakeholders to provide feedback on the draft. Manufacturers, quality professionals, and regulatory experts can submit their comments electronically via Regulations.gov.

Engaging during this period gives industry professionals an opportunity to shape the final version of the QMSR guidance and ensure it remains practical, globally relevant, and aligned with modern manufacturing practices.

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Why This Matters

This transition represents more than a regulatory update — it’s a strategic modernization of how medical device quality is managed and evaluated. By embracing ISO 13485 principles, the FDA is reinforcing its commitment to:

• Global harmonization of quality standards
• Patient safety and product reliability
• Streamlined regulatory reviews and inspections

As the February 2026 effective date approaches, manufacturers should begin assessing their current QMS documentation and preparing for compliance with the updated requirements.

Final Conclusion

The FDA’s draft guidance on QMS requirements marks a significant advancement toward a unified global approach to medical device quality. For manufacturers, it’s a call to strengthen their systems, focus on risk management, and align with the international quality framework that underpins today’s regulatory expectations.

This initiative underscores FDA’s ongoing mission to protect public health through quality assurance, transparency, and continuous improvement — from design to delivery.

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