26 Feb 2026 Silver Spring, MD. The USFDA, as the Regulatory Authority Council (RAC) Chair and Secretariat for the Medical Device Single Audit Program (MDSAP) for 2026 and 2027, started the audit year off with a bang, updating the MDSAP Audit Approach, used by the fifteen MDSAP AOs (Auditing Organisations) during MDSAP audits for an improved alignment with requirements in the recently established Quality Management System Regulation (QMSR) for MDSAP certified medical device manufacturers.
Thousands of medical device manufacturers have relied on voluntary participation in the MDSAP Certification process to streamline and unify USFDA, Canadian, Australian, Brazilian, and Japanese inspections with a single scheduled audit which is also integrated with ISO 13485 certification requirements. Each year, medical device manufacturers know exactly what to expect on the MDSAP facility audit by following the MDSAP Audit Approach document. When the Audit Approach revises, it’s critical for the medical device manufacturer to review the changes, and, where appropriate, update the QMS, which may involve updating procedures, forms, training, and internal auditing.
The revised MDSAP Audit Approach has replaced references to the former Quality System Regulation, or QSR, with those from the QMSR which was published and made effective earlier this month. The QMSR aligns FDA manufacturer requirements with those of ISO 13485. For more information, click here.
In addition to the document now referencing requirements of the QMSR throughout, it has replaced the term “critical supplier” in the Terminology section with ‘suppliers that should be considered for audit as part of the MDSAP audit of the organization.” In Measurement, Analysis, and Improvement process, Requirements for Australia’s TGA Uniform Recall Procedure for Therapeutic Goods (URPTG) have been replaced with the Procedure for recalls, product alerts, and product corrections (PRAC). There have also been three Device Marketing Authorisation and Facility Registration changes including:
– updating Brazil’s ANVISA references RDC no 36/2015 with 830/2025 and 40/2015 with 751/2022,
– updating FDA requirement to update device listings between 1 Oct and 31 Dec, or at its discretion, at the time the change occurs, and
– adding FDA PCCP (Predetermined Change Control Plans) to be reviewed during the audit if applicable (if the manufacturer has submitted to FDA and FDA has accepted a PCCP as part of an Artificial Intelligence (AI) enabled 510(k) clearance or PMA approval. – ,
Based on recent feedback from CRO Group clients, AO auditors are likely to emphasize Risk Management (RM) throughout the audit process – in addition to the familiar focus during Design and Development, also in Measurement, Analysis and Improvement for CAPA and Complaint Investigation, PFMEAs while auditing Manufacturing, and Supplier Controls while auditing Purchasing.
This is the 10th revision of the Audit Approach document – and the entire MDSAP auditing program is not even ten years old! There have been revisions every year or two, sometimes two in a year. CRO Group clients are never surprised by these revisions – we make it easy – informing manufacturers what needs to be updated in the documented QMS, providing training and internal auditing to ensure readiness before the MDSAP auditors arrive. For more information, click here. To obtain your own copy of the revised MDSAP Audit Approach, click here.