The new Quality Management System Regulation (QMSR) comes into effect on February 2, 2026, following the publication of the Final Rule on February 2, 2024, which amends the previous 21 CFR Part 820 – Quality System Regulation (QSR).

This is one of the most significant regulatory updates in recent decades for those placing Medical Devices on the U.S. market.

The objective of the reform is clear: to harmonize the requirements of the Current Good Manufacturing Practice (cGMP) for Medical Devices with the international standard ISO 13485:2016.

With the QMSR, the FDA rewrites Part 820 by incorporating ISO 13485:2016 by reference, adopting its structure and main requirements. This approach reflects the FDA’s strategy to simplify the regulatory framework and promote global harmonization, reducing the differences between the obligations required in the United States and those mandated by other regulatory authorities.

What is the QMSR and its Role in Harmonization?

The QMSR replaces the previous 21 CFR Part 820 and incorporates the 2016 edition of the ISO 13485:2016 standard by reference. The update pursues the FDA’s aims for regulatory simplicity and global harmonization because it adopts the quality management system requirements used by numerous other regulatory authorities worldwide.

Strategic Objectives and Benefits

  • Global Harmonization

Alignment with ISO 13485:2016 strengthens participation in the MDSAP (Medical Device Single Audit Program), which includes Canada, Australia, Brazil, and Japan. This alignment of the U.S. Quality Management System is also valuable for the European Union: companies already compliant with ISO 13485:2016 for the European MDR will see the conformity path to the American market accelerated and simplified. Essentially, harmonization speeds up conformity procedures and market access in multiple countries simultaneously.

  • Reduced Burden

Official FDA estimates indicate an annualized net cost savings (benefits) of approximately $532 million (7% discount rate) or $554 million (3% discount rate), thanks to the possibility of maintaining a single quality system for multiple markets.

  • Maximization of Inspection Resources

Harmonization allows for greater efficiency in allocating inspection resources. If a company already has a robust QMS based on ISO 13485:2016, FDA inspectors can focus on FDA-specific critical areas.

  • Market Access and Benefits

A more efficient and globally recognized Quality Management System ensures that manufacturers (U.S. and non-U.S.) can place safe and effective Medical Devices on the market, bringing clinical benefits to patients more quickly and predictably.

Key Points of Integration

The core of the change is the direct incorporation of ISO 13485:2016 into the structure of the new Quality Management System Regulation (QMSR), which adds specific supplementary sections (e.g., §820.7, §820.10, §820.35, §820.45).

  1. Emphasis on Risk and the Life Cycle

While the risk approach in 21 CFR 820 was only partially explicit, the QMSR makes it central to the entire quality system.

  • The Risk Management process must be extended throughout the entire product life cycle.
  • Conformity to the ISO 14971 standard is recognized as a tool to document product risk management.
  1. Explicit Controls on the Quality Management System and Audits

The Quality Management System Regulation (QMSR) explicitly details requirements that were less detailed in the previous 21 CFR QSR.

  • QMS Implementation: The requirement to implement a Quality Management System is explicitly stated (§820.10).
  • Internal Audits and Management Review: Internal Audits and Management Review are made explicit requirements (consistent with ISO 13485:2016) and, unlike the QSR, the related reports are now fully subject to FDA inspection.
  • Document Control: Control over documents and records is aligned with ISO 13485:2016, with a dedicated section (§820.35) that also integrates FDA-specific requirements.
  1. Customer Satisfaction and Improvement

These two aspects, pillars of ISO 13485:2016, take on crucial importance.

  • The concept of Customer Satisfaction requires the QMS not only to manage complaints but to actively use feedback to monitor device performance.
  • The Continuous Improvement of the QMS becomes a fundamental element for demonstrating the quality system’s effectiveness over time.
  1. Record Management and Documentation

Control over documents and records is aligned with ISO 13485:2016 but integrated with specific FDA needs, particularly in the new section §820.35.

  • Although the old acronyms DMR (Device Master Record), DHR (Device History Record), and DHF (Design History File) are no longer explicitly mentioned in the QMSR, the substantial requirements are maintained and covered by the documented structure provided by ISO 13485:2016, which includes the Medical Device File and traceability and development records.
  • The QMSR, through §820.35, clarifies that records must include documentation related to Adverse Events and Recalls and clarifies aspects of confidentiality and protection of information.
  • The new section §820.45 introduces additional controls on Labeling and Packaging, requiring procedures that ensure the visual verification of labels for accuracy, a more stringent requirement than mere automation.

Impact and Strategy: What to Do?

February 2, 2026, is the final deadline by which the Quality Management System (QMS) must be fully aligned with the requirements of the new QMSR, based on ISO 13485:2016.

Manufacturers placing Medical Devices in the United States who have only followed 21 CFR Part 820 must adapt their Quality Management System.

This is not a new implementation from scratch. However, an accurate internal review (Gap Assessment) is essential.

While companies already compliant with ISO 13485:2016 have a significant advantage, those who have operated exclusively under 21 CFR Part 820 must carefully check the differences, focusing in particular on:

  • Risk management;
  • QMS documentation and related definitions;
  • Customer satisfaction;
  • Continuous improvement of the QMS.

Next Steps

  1. Perform a Gap Assessment: Compare internal processes with QMSR/ISO 13485:2016 requirements.
  2. Update Documentation: Review procedures to reflect ISO terminology.
  3. Prepare for Inspections: Be ready for FDA inspections that will examine the Quality Management System comprehensively, including internal audit records.

FDA Draft Guidance

In October 2025, the FDA published a Draft Guidance titled “Quality Management System Information for Certain Premarket Submission Reviews.”

This document, open for public comment and not yet final, provides clarifications on the QMS information (based on ISO 13485:2016 terminology) that must be included in PMA and HDE approval requests. The document reinforces FDA’s expectations, particularly concerning internal audit records, which become accessible to inspectors with the QMSR. Official guidelines are awaited.

>>> Thema offers full support in gap analysis and the implementation of necessary actions to ensure full compliance with the new QMSR (Quality Management System Regulation), guaranteeing operational continuity and access to the U.S. market.

SOURCES:
https://www.govinfo.gov/app/details/FR-2024-02-02/2024-01709

Quality Management System Information for Certain Premarket Submission Reviews | FDA