On February 23, 2022, the FDA published a proposed rule for the new Quality Management System Regulation (QMSR). The QMSR aims to align the current good manufacturing practice (cGMP) requirements of the FDA's Quality System Regulation (QSR) with ISO 13485:2016, the internationally recognized quality management standard for medical devices.

Background: A Long-Awaited Milestone

The proposal generated significant interest in the medical device industry, as discussions about harmonizing the FDA's QSR with ISO 13485 had been ongoing since 2018.

In 2023, Jeff Shuren, then director of the FDA's Center for Devices and Radiological Health (CDRH), spoke at the annual Food and Drug Law Institute (FDLI) conference in Washington, DC. He said the center hoped to publish the final rule that year: "It is a matter of high priority, and we are optimistic about releasing it by the end of this year."

At the time, the unified agenda listed December 2023 as the expected publication date for the final rule. Either way, the proposed rule marked a major step toward the harmonization medical device professionals had long expected.

So why did the FDA pursue harmonization, what changes were expected, and how does it affect medical device companies?

The Motivation Behind QMSR

Over the past two decades, ISO 13485 has been revised several times, while the QSR remained largely unchanged since its release in 1996.

In the proposed rule, the FDA acknowledged that "regulatory expectations for a QMS have evolved since the current part 820 was implemented over 20 years ago." By incorporating ISO 13485 by reference, the agency aimed to explicitly require internationally recognized QMS expectations for devices under its jurisdiction.

The FDA found that the 2016 version of ISO 13485 closely aligns with 21 CFR Part 820. ISO standards are reviewed every five years, and ISO 13485 was last confirmed in 2020 at the time of the proposal.

The FDA stressed that Part 820 and ISO 13485 are largely similar, noting that "where ISO 13485 diverges from the current part 820, these differences are generally consistent with the overall intent and purposes behind FDA's regulation of QMSs."

Expected Benefits

• Less duplication: many companies struggled to meet both the QSR and ISO 13485 separately.
• Regulatory simplicity: the FDA expected harmonization to support "regulatory simplicity and global harmonization."
• Better patient access: lower compliance burdens help bring needed devices to patients more efficiently.
• Cost savings: the FDA estimated savings of at least $439 million for medical device companies over the following decade.

QMSR vs. QSR

Incorporating ISO 13485 "by reference" brings significant changes to 21 CFR Part 820, as the QMSR references specific requirements from ISO 13485:2016.

According to the FDA, the proposed rule added definitions, clarified concepts, and introduced requirements that manufacturers must meet within their QMS in addition to ISO 13485.

Mostly Semantic Changes

Many changes are semantic and do not alter core QMS requirements. For example, the term "device master record" was dropped because ISO 13485 does not use it, and the concept is covered by ISO 13485's medical device file requirement.

FDA Definitions Take Priority

Where ISO 13485 terms conflict with the Federal Food, Drug, and Cosmetic Act and its regulations, FDA definitions prevail. For instance, the FDA's "device" and "labeling" supersede ISO 13485's "medical device" and "labelling." The FDA's reasoning is set out in Section 5, Part B of the proposed rule.

New Sections in Part 820

• Section 820.7: Incorporation by reference
• Section 820.10: Requirements for a quality management system
• Section 820.15: Clarification of concepts
• Section 820.35: Control of records
• Section 820.45: Device labeling and packaging controls

Greater Emphasis on Risk Management

A notable difference is ISO 13485's emphasis on risk management. The FDA already expected manufacturers to integrate risk management throughout the QMS and product lifecycle, but ISO 13485 makes these requirements explicit. By incorporating it, the QMSR places clearer emphasis on risk management in design controls.

Implications of QMSR for Medical Device Companies

The FDA already considers ISO 13485 substantially similar to the QSR. This means the transition does not require a complete overhaul of your QMS. The goal of harmonization is to simplify processes for everyone involved.

Key Points from the Proposed Rule

1. The proposal included a one-year transition before the rule took effect. The final rule extended this to two years, with an effective date of February 2, 2026.
2. The FDA's QSIT inspection approach would be replaced with one aligned to the QMSR.
3. The FDA harmonized with ISO 13485:2016. Any future revisions of ISO 13485 will be evaluated by the FDA before being incorporated.
4. An FDA inspection does not result in an ISO 13485 certificate, and holding an ISO 13485 certificate does not exempt a manufacturer from FDA inspections.

Staying informed about the FDA's approach helps medical device manufacturers manage regulatory change effectively. For a practical checklist, see our 2025 Compliance Roadmap for Importers and Distributors.