QMSR: What the U.S. FDA’s New Inspection Manual Really Means for Device Manufacturers

By Luana Zerafa and Evangeline Loh

Background

February 2, 2026, marks the start of the US FDA Quality Management System Regulation (QMSR), 21 CFR 820.  For some time, the U.S. Food and Drug Administration (FDA) has been assessing alignment with ISO 13485. In 2022, the FDA issued a proposed rule to this effect. And, in February 2, 2024, the final rule. 

FDA QMSR

The QMSR incorporates by reference the international QMS standard (ISO 13485:2016). In the Federal Register (89 FR 723) Section III Background, F, General Overview of the Final Rule, FDA stated: 

“One goal for this rulemaking is to simplify and streamline the regulation. Where possible, we either are accepting the incorporated requirement without modification or are creating a requirement that will supersede the correlating requirement in ISO 13485. There are a few exceptions where we are clarifying concepts or augmenting specific clauses in ISO 13485, but overall, we are not modifying the clauses in ISO 13485. This approach helps further regulatory convergence.”

Emergo experts assessed the differences and presented additional requirements in a previous blog. 

FDA activities between final rule and February 2, 2026

The FDA updated its website, posted references, issued documents and provided training materials. One of the helpful documents is a Q & A on the QMSR. In one of the responses, the FDA clarified that records generated before February 2, 2026 were also within FDA inspectional remit. 

In addition, on January 30, the US FDA published its updated Compliance Program Manual.

FDA Compliance Program Manual – What this means for manufacturers starting today

The U.S. FDA updated Compliance Program Manual is titled Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). This is more than a procedural update and fundamentally changes how FDA will inspect medical device manufacturers. The new QMSR inspection strategy shifts the focus from subsystem auditing to a risk‑based evaluation of the entire system, aligning ISO 13485 audits with FDA’s added emphasis on patient safety, MDR compliance, UDI accuracy, and risk‑based decision‑making. Manufacturers should expect inspectors to:

• Evaluate at least one element of each of the six QMS Areas (Management Oversight, Design & Development, Change Control, Outsourcing & Purchasing, Product & Service Provision and Measurement Analysis and Improvement) and four other applicable FDA requirements not covered by ISO 13485 (21 CFR 803, 21 CFR 806, 21 CFR 821, 21 CFR 801 & 21 CFR 830) in surveillance inspections.
• Prioritize areas where product risk can adversely impact patients and apply “critical thinking”.
• Scrutinize risk management documentation as the backbone of inspection flow.
• Request management review, internal audit, and supplier audit reports, which are now explicitly reviewable.
• Expand use of Remote Regulatory Assessments (RRAs) ahead of or instead of on-site inspections.  RRAs represent a structural change in how the FDA oversees quality systems. The FDA can “inspect” manufacturers without setting foot on-site. If FDA believes it can assess compliance from documents and evidence, it will. RRAs may accelerate inspection timelines by gathering information before inspectors arrive, for example. 

Concluding remarks

With the QMSR now in effect, and the new inspection manual guiding the FDA’s oversight, manufacturers should urgently reassess their readiness. This means:

• Validating that the ISO 13485 QMS is fully aligned with the FDA’s added expectations;
• Strengthening the risk management documentation and linkage to the decisions made in the QMS;
• Validating that Management Review, Internal Audits, and Supplier Audits can withstand FDA scrutiny; and,
• Preparing for more sophisticated risk‑based questioning during inspections.

The QMSR is not simply a regulatory update; it signals the FDA’s shift toward global harmonization, higher transparency expectations, and more proactive oversight tools such as RRAs. It also acknowledges the FDA’s ongoing commitment to advancing the activities of the International Medical Device Regulators Forum (IMDRF). 

As manufacturers adapt, Emergo experts are ready to support global QMS alignment, MDSAP readiness, and inspection preparedness across the evolving regulatory landscape.