The landscape of global medical device compliance officially shifted on February 2, 2026. With the U.S. FDA’s Quality Management System Regulation (QMSR) now in full effect, the Medical Device Single Audit Program (MDSAP) has released its latest revision: MDSAP AU P0002.10.
Goodbye QSR, Hello QMSR
The most significant change in the 2026 revision is the transition from 21 CFR Part 820 (QSR) to the Quality Management System Regulation (QMSR).
In previous versions, auditors treated the FDA’s QSR and ISO 13485 as parallel (though similar) requirements. In version 10, the audit approach shifts to an ISO 13485-first mentality. The QMSR essentially “plugs into” the ISO standard, meaning auditors will now focus on your ISO-compliant processes while verifying specific FDA-supplemental requirements where they still exist (such as unique labeling and record-keeping rules).
Key Changes at a Glance
1. PCCPs
For the first time, the Audit Approach explicitly addresses the FDA approach to Predetermined Change Control Plans (PCCP) in Chapter 2, Task 3 – Notification of Changes to Marketed Devices or to the QMS. As AI-enabled devices and Software as a Medical Device (SaMD) become the norm, auditors are now tasked with:
- Verifying that software modifications remain within the boundaries of an FDA-cleared PCCP.
- Ensuring that change control SOPs specifically address how these boundaries are maintained.
2. Records
Consistent with the other country-specific requirements as well as the updated FDA Inspection Guide, internal audit reports, supplier audit reports, and management review records are in now reviewed for US compliance.
3. Jurisdiction-Specific Clean-up
The revision also sweeps up several global regulatory changes that have matured since 2024:
- Brazil (ANVISA): Updates to reflect the full implementation of RDC 751/2022 and RDC 830/2023.
- Australia (TGA): Updated references for software-based medical device classifications and “Comparable Overseas Regulator” pathways.
- Japan (MHLW): Finalization of the transition to the 2021 amendment of Ordinance 169.
The Bottom Line:
Version 10 of the MDSAP Audit Approach is less about new rules and more about alignment.
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