MDSAP Audit Approach Update: What Changed and Why It Matters

Date: February 2, 2026
Category: US Regulations
Description: The revised MDSAP Audit Approach was issued on February 2, 2026, with the document carrying a revision date of February 6, 2026. Its release closely follows the FDA’s Quality Management System Regulation (QMSR) effective date of February 2, 2026, marking a significant step in the FDA’s formal alignment with ISO 13485.
One of the most notable changes in this revision is how regulatory references are handled throughout the audit model. The Audit Approach removes references and citations to the FDA Quality System Regulation across the document, while continuing to map audit tasks to ISO 13485 clauses and applicable country-specific requirements. This shift reflects a clearer emphasis on ISO 13485 as the foundational structure for MDSAP audits.
Importantly, this update does not eliminate FDA-specific expectations. References to U.S. regulatory requirements, including 21 CFR Part 820, remain present in targeted areas where FDA requirements continue to require explicit attention. These include document and record controls, device marketing authorization and establishment registration, post-market surveillance and complaint handling, adverse event and advisory notice reporting, design and development controls, and production, servicing, and traceability records.
From a practical perspective, this revision represents continued regulatory harmonization rather than a reduction in audit rigor. Manufacturers are still expected to demonstrate a robust and well-integrated quality management system. What has changed is the expectation that ISO 13485 processes clearly support FDA requirements, rather than operating as parallel or duplicative systems.
For organizations participating in MDSAP, the implications are clear. Quality systems should already be structured to support this level of alignment. Companies that continue to manage ISO 13485 compliance and FDA compliance as separate efforts may encounter challenges during audit preparation and execution.
Overall, the update reinforces a broader industry trend toward integrated, mature quality systems. Manufacturers with cohesive, well-documented processes are likely to navigate this transition smoothly. Those relying on fragmented or reactive compliance approaches may find audits more demanding as expectations around system integration become more explicit.
The revised MDSAP Audit Approach is available here: Audit Approach | Medical Device Single Audit Program (MDSAP)