From QSR to QMSR: The FDA’s Historic Transformation of Medical Device Quality System Regulation

Background and Regulatory Proposal

On February 23, 2022, the FDA published a proposed amendment to harmonize the existing QSR (Quality System Regulations: 21 CFR Part 820) with ISO 13485:2016. The proposed regulation to harmonize the QSR with ISO 13485:2016 was designated as the “Quality Management System Regulations (QMSR).”

The QMSR was intended to incorporate the requirements of ISO 13485:2016, thereby aligning many of its provisions with the international standard. Concurrently, the FDA planned to impose additional requirements upon ISO 13485:2016 specifications, particularly regarding the retention of records such as complaint files.

From Regulatory Proposal to Final Rule

Since October 7, 1996, when the current QSR became effective, the regulation had functioned as the United States’ medical device quality system requirement for nearly three decades. During this period, although the QSR underwent minor modifications, no substantive revision was implemented.

On January 31, 2024, the FDA’s longstanding international harmonization efforts came to fruition with the publication of a final rule. This final rule was formally published in the Federal Register on February 2, 2024, with an effective date of February 2, 2026. This two-year transition period was established to allow medical device manufacturers adequate time to migrate their quality management systems from QSR to QMSR compliance.

The FDA’s impetus for pursuing this transition from QSR to QMSR was driven by a strong desire to consolidate U.S. regulatory requirements with those employed by other major regulatory authorities. Within the context of existing international harmonization frameworks such as the Medical Device Single Audit Program (MDSAP), this transformation represents a significant advancement in the global alignment of medical device regulation.

Key Points of Amendment: Incorporation of ISO 13485:2016

Incorporation by Reference Methodology

The FDA chose to incorporate ISO 13485:2016 “by reference” (rather than by transcription) into Part 820, thereby aligning its requirements with those of other regulatory authorities using ISO standards. This distinction is significant. Unlike Japan’s approach, which incorporates ISO 13485:2016 requirements directly into the ordinance text (Chapter 2) and specifies additional requirements in a separate chapter (Chapter 3), the QMSR employs a reference methodology. This approach provides flexibility for future responsiveness to ISO standard revisions.

Revision of Regulatory Title and Application Policy

The amendment changes the title of Part 820 from “Quality System Regulations (QSR)” to “Quality Management System Regulations (QMSR).”

Under the QMSR, the existing Part 820 QSR requirements are withdrawn as a general principle, with ISO 13485:2016 requirements adopted in their place. Critically, the QMSR does not modify the requirements of ISO 13485:2016 itself; the international standard’s provisions are adopted as written.

Retention and Addition of FDA-Specific Definitions

However, certain definitions from the current QSR are retained or modified and maintained within the QMSR. In other words, requirements that exist in the QSR but not in ISO 13485:2016 are incorporated into the QMSR. This approach involves accepting ISO 13485:2016 requirements as written while adding FDA-specific requirements.

Additionally, FDA-specific requirements and provisions are added to clarify particular concepts used in ISO 13485:2016. These elements include provisions necessary to ensure compliance with the U.S. Federal Food, Drug & Cosmetic Act (FDCA).

Incorporation of ISO 9000:2015 Clause 3 (Terms and Definitions)

The QMSR incorporates, by reference, not only ISO 13485:2016 but also Clause 3 of ISO 9000:2015 (Terms and Definitions). Since ISO 13485:2016 is dependent upon ISO 9000:2015 for its foundational terms and definitions, this incorporation is essential for comprehensive regulatory compliance.

Substantive Character of QMSR Requirements

Essential Continuity with Existing QSR

As a whole, the existing Part 820 (QSR) requirements are substantively equivalent to ISO 13485:2016 requirements. Consequently, the QMSR requirements are substantively equivalent to the QSR. This is because QSR-specific requirements are maintained within the QMSR.

Key Takeaways:

• QMSR requirements are substantively equivalent to existing QSR requirements
• The regulation incorporates ISO 13485:2016 by reference with additional requirements superimposed
• QMSR compliance is designed to parallel ISO 13485:2016 compliance

Terminology Changes

With the transition to QMSR, terminology modifications occur. Traditional terms such as “Device Master Record (DMR),” “Design History File (DHF),” and “Device History Record (DHR)” do not explicitly appear in the QMSR regulatory text. However, this does not signify the elimination of documentation requirements; rather, these requirements have been integrated into the corresponding ISO 13485:2016 provisions (such as “design and development files”).

QMSR-Specific Additional Requirements Beyond ISO 13485:2016

While based on the international standard, the QMSR incorporates additional requirements necessary to satisfy U.S. regulatory mandates. These are enumerated as follows:

1. Record Requirements (§ 820.35)

Record management is critical to substantiating the safety and effectiveness of medical devices. The QMSR explicitly specifies the following elements:

• Signatures and dates of record approvers
• Specific retention requirements for records of medical device complaints
• Records pertaining to ancillary services
• Records related to UDI (Unique Device Identifier)
• Handling of confidential records

These requirements are areas that receive particular attention during FDA inspections.

2. Labeling and Packaging Requirements (§ 820.45)

According to FDA reports, a considerable proportion of medical device recalls are attributable to labeling and packaging deficiencies. Accordingly, the QMSR introduces a new section (§ 820.45) that establishes requirements for detailed procedures governing labeling and packaging activities. This requirement exceeds the general mandate of ISO 13485:2016 Clause 7.5.1(e), explicitly requiring the establishment of “detailed procedures to ensure the integrity, inspection, storage, and operations for labeling and repackaging activities.”

3. UDI (Unique Device Identifier) Requirements (§ 820.10 References Part 830)

UDI is fundamental to the FDA’s medical device identification system. Following QMSR implementation, UDI-related requirements will be referenced from Part 830.

4. Traceability Requirements (§ 820.10 References Part 821)

The ability to trace medical devices is indispensable for post-market surveillance and recall response. The QMSR clarifies specific traceability requirements by reference to Part 821.

5. Adverse Event Reporting Requirements (§ 820.10 References Part 803)

Serious adverse events associated with medical devices must be reported to the FDA pursuant to Part 803. Following QMSR implementation, these requirements are integrated into Part 820.

6. Recall Requirements (§ 820.10 References Part 806)

Requirements for medical device recall procedures are specified in Part 806 and continue to apply after QMSR implementation.

Record Composition Elements Achievable Through ISO 13485 Compliance

The following record composition elements are deemed achievable through adherence to appropriate ISO 13485:2016 provisions and are therefore not individually specified in the QMSR. This signifies that these requirements have not been eliminated but rather integrated into corresponding ISO standard provisions:

• Design History File (DHF) (Current § 820.30(j)) → Integrated into ISO 13485 Clause 8.3 design and development control requirements
• Device Master Record (DMR) (Current § 820.181) → Integrated into ISO 13485 Clause 8.5.2 production control requirements
• Device History Record (DHR) (Current § 820.184) → Integrated into ISO 13485 Clause 8.5.3 traceability requirements
• Quality System Record (Current § 820.186) → Integrated into ISO 13485 Clause 4.2.4 documentation requirements

This integrative approach ensures that manufacturers maintaining full ISO 13485:2016 compliance will continue satisfying these requirements following QMSR implementation.

The Relationship Between FDA Inspection and ISO 13485 Certification

Modification of Inspection Process

Concurrent with QMSR finalization, the FDA’s inspection approach undergoes significant transformation. The current Quality System Inspection Technique (QSIT) will be formally withdrawn on February 2, 2026, the QMSR effective date.

With this withdrawal, a new inspection process will be implemented. This new process will be documented in a revised version of the FDA’s Compliance Program (CP), titled “Inspection of Medical Device Manufacturers.” The revised CP becomes effective on February 2, 2026, and will be available on the FDA’s device CP public webpage no later than the QMSR effective date.

A significant change involves the inclusion of documents previously protected under the QSR—specifically management review reports, internal audit reports, and supplier audit reports—as subjects of FDA inspection under the QMSR. The FDA justifies this change by noting that ISO 13485:2016 contains no such protective provisions and that manufacturers are required to produce such documents for other regulatory authorities.

Relationship Between ISO 13485 Certification and FDA Inspection

Several critical points require explicit clarification:

• FDA inspection does not result in issuance of ISO 13485 certification
• Possession of an ISO 13485:2016 certificate of conformity does not exempt manufacturers from FDA inspection
• The FDA does not maintain an ISO 13485 certification program
• Although QMSR incorporates ISO 13485, manufacturers holding ISO 13485 certification receive no regulatory burden reduction from the FDA

However, manufacturers participating in the Medical Device Single Audit Program (MDSAP) are excluded from routine FDA inspection. This exclusion results from unified audit procedures conducted within the MDSAP framework, wherein ISO 13485:2016 compliance is confirmed through a coordinated audit process.

Characteristics of the New Inspection Approach

The new inspection approach under QMSR incorporates several significant features. Inspections will focus on confirming an integrated, traceability-emphasizing quality management system that functions across all subsystems. Furthermore, risk-based decision-making will be evaluated with greater rigor not merely in design verification but throughout the quality system. This reflects ISO 13485:2016’s more integrated incorporation of ISO 14971 (risk management) principles.

Practical Implementation Challenges and Preparation for QMSR Transition

Economic Impact on Industry

The FDA estimates that QMSR implementation will produce annual net cost savings to the medical device industry of approximately $532 million (at 7% discount rate) to $554 million (at 3% discount rate). These figures include qualitative benefits such as more rapid patient access to medical devices.

Critical Actions Required of Manufacturers

Prior to the February 2, 2026 QMSR effective date, medical device manufacturers must implement the following actions:

Comprehensive review and revision of QMS documentation hierarchies, internal audit processes, and training materials; amendment of relevant agreements, including supplier quality agreements. Most critically, manufacturers with ongoing PMA (Premarket Approval) or HDE (Humanitarian Device Exemption) applications must carefully manage scheduling, as the transition from QSR to QMSR requirements coincides with submission timelines. Manufacturers subject to recent QSR compliance findings must simultaneously address QSR-identified deficiencies while preparing for QMSR implementation, as regulatory authorities have not provided a transition grace period.

Access to ISO 13485:2016

Access to ISO 13485:2016 and ISO 9000:2015 Clause 3 is provided through the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal. ISO 13485:2016 is available for download following user registration. ISO 9000:2015 Clause 3 is accessible without charge through the ISO Online Browsing Platform but is not available for download.

Conclusion

The transition from QSR to QMSR represents a historic transformation within FDA medical device regulation. This amendment is the culmination of the FDA’s decades-long effort to harmonize U.S. medical device regulation with international standards.

For manufacturers, the critical understanding is that QMSR implementation does not constitute a simple substitution of equivalent requirements but rather signifies a transition toward a more comprehensive quality system approach encompassing integrated risk management, modified inspection processes, and expanded record disclosure scope. The approximately one-year transition period until February 2, 2026, though limited, represents a critical opportunity window for addressing these transformations.

Medical device manufacturers must approach this transition as a genuine qualitative evolution of their quality systems rather than merely a regulatory terminology substitution, capitalizing fully on the available preparation period.