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

[0:50] QMSR: The biggest shakeup to US quality requirements since 1996.
[2:00] Effective Date: February 2, 2026—the clock is ticking.
[2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.
[3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).
[5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).
[6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).
[7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).
[8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.
[10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.
[13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.
[17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).

#438: QMSR Mythbusters Episode

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