#438: QMSR Mythbusters Episode

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.

The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.

Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).

Key Timestamps

1. [0:50] QMSR: The biggest shakeup to US quality requirements since 1996.
2. [2:00] Effective Date: February 2, 2026—the clock is ticking.
3. [2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.
4. [3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).
5. [5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).
6. [6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).
7. [7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).
8. [8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.
9. [10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.
10. [13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.
11. [17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).
12. [17:35] Retained Req. A: Mandatory Record Keeping Content (21 CFR Part 820.35)—UDI/UPC in complaint/service records.
13. [19:00] Retained Req. B: Extended Record Retention Period (Device life, no less than two years).
14. [20:10] Retained Req. C: Specific Labeling and Packaging Controls (21 CFR Part 820.45)—Inspection for accuracy.
15. [22:00] Immediate Action Plan: Gap analysis and restructuring to the new terminology.

Quotes

"Your internal audit reports, your management review minutes, if you were expecting to keep those shielded from any outside eyes, they are now inspectable regulatory evidence." - Etienne Nichols

Takeaways

1. Mandatory Regulatory Mapping: Manufacturers must conduct a thorough mapping exercise to ensure their existing DMR, DHF, and DHR content fulfills the new requirements of the Medical Device File (MDF), Design and Development File (DDP), and Batch/Lot Records, respectively.
2. Embed Lifecycle Risk Management: The QMSR requires a holistic, lifecycle approach to risk management, making it an explicit core component of all QMS clauses (e.g., supplier controls, design and development), moving beyond isolated, perfunctory steps.
3. Prepare for Full Documentation Exposure (Regulatory): Recognize that the former privilege is gone; internal audit reports, supplier audit reports, and management review records are now subject to routine FDA inspection. Draft these documents with the utmost rigor and awareness of their new status as regulatory evidence.
4. Confirm Compliance with FDA Retained Sections: ISO 13485 certification is not enough. You must address the US-specific requirements retained under the prevalence rule, particularly the mandatory inclusion of UDI/UPC in complaint records (§ 820.35) and the strict labeling/packaging inspection controls (§ 820.45).
5. Transition is Immediate: The compliance date of February 2, 2026, is a hard deadline. Proactive gap analysis, process restructuring, and staff training based on the QMSR's requirements and the FDA's preamble are essential for uninterrupted market access.

References

1. ISO 13485:2016: The international Quality Management System standard for medical devices incorporated by reference into the QMSR.
2. 21 CFR Part 820 (New QMSR): The revised Code of Federal Regulations that replaces the QSR, incorporating ISO 13485 and retaining US-specific supplemental provisions.
3. 21 CFR Part 820.35 (Control of Records): Retained section requiring specific content, like UDI/UPC, for complaint and service records.
4. 21 CFR Part 820.45 (Device Labeling and Packaging Controls): Retained section requiring documented procedures for inspecting labeling and packaging accuracy.
5. QMSR Preamble: The FDA's detailed commentary and response to comments, which is crucial for understanding the Agency's interpretive thinking behind the new rule.
6. Etienne Nichols' LinkedIn: https://www.linkedin.com/in/etienne-nichols/

MedTech 101 Section

What is the "Prevalence Rule"?

The Prevalence Rule is a key concept in the new Quality Management System Regulation (QMSR) that clarifies which set of rules takes priority. Since the FDA is incorporating the international standard ISO 13485:2016 by reference, a conflict could arise between the ISO standard and existing U.S. law. The Prevalence Rule dictates that in any area of conflict, the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations (like those retained in 21 CFR Part 820) will always supersede the ISO 13485 requirement. Think of it like a recipe: ISO 13485 is the main set of instructions, but the retained 21 CFR sections are non-negotiable, mandatory additions or modifications that must be followed regardless of what the main instructions say. This is why mere ISO certification does not guarantee QMSR compliance.

Sponsors

This episode is brought to you by Greenlight Guru. As the medical device industry faces the significant shift to the QMSR, your QMS needs to be audit-ready and easy to update. Greenlight Guru offers an all-in-one MedTech lifecycle excellence platform with specialized QMS and EDC solutions. Our electronic Quality Management System (eQMS) is built to facilitate the traceability and document control necessary to manage the new ISO-aligned terminology and retained FDA requirements, while our Electronic Data Capture (EDC) software helps manage high-quality data for clinical trials. Don't let scattered documentation hold you back from the February 2026 deadline. Visit www.greenlight.guru to learn how we can help you streamline your quality system and get back to innovating.

Feedback Call-to-Action

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