FDA Transitions to QMSR, Updating How Medical Device Inspections Are Conducted

As of February 2, 2026, the FDA has transitioned to a new inspection approach for medical device manufacturers, aligning its oversight with internationally recognized quality system standards.

At a practical level, the change affects how the FDA evaluates whether manufacturers are meeting quality and safety requirements. Instead of organizing inspections around separate subsystems, investigators now review how a manufacturer has established, documented and maintains its quality management processes across the device lifecycle. The inspection objective remains to assess compliance with applicable design, manufacturing and quality system requirements.

This update is more than a procedural change. It changes how inspections are structured and conducted, while preserving the FDA’s existing legal authority and enforcement expectations.

From QSIT to QMSR

With the Quality Management System Regulation (QMSR) now in effect, FDA investigators are conducting inspections using the updated Inspection of Medical Device Manufacturers Compliance Program (7382.850).

As part of this transition, the FDA has stopped using inspection manuals associated with the Quality System Inspection Technique (QSIT). QSIT organized inspections using a defined set of inspection subsystems, including corrective and preventive actions, production controls and design controls. Under QMSR, inspections are conducted using an approach aligned with the updated compliance program.

What Is QMSR?

QMSR updates FDA’s device quality system requirements under 21 CFR Part 820 by formally adopting the ISO 13485:2016 international standard. Put simply, 21 CFR Part 820 defines FDA’s quality requirements for medical device manufacturing, while ISO 13485 describes how manufacturers should organize and maintain a quality management system.

In practice, this means the FDA has adopted the same quality management system framework used by many other regulatory authorities. ISO 13485 sets requirements for how manufacturers document, implement and maintain processes that support device quality during design, manufacturing and postmarket activities that FDA may review during inspections.

Who the Regulation Applies To

QMSR applies to manufacturers of finished medical devices intended for commercial distribution in the US. A finished device includes any device or accessory that is suitable for use or capable of functioning, even if it is not yet packaged, labeled or sterilized.

Certain accessories are considered finished devices and are therefore also subject to QMSR requirements.

What Inspections Will Focus On

Under the QMSR inspection model, FDA investigators assess whether a manufacturer’s quality management system is established, implemented and maintained in compliance with FDA requirements.

Certain lower-risk and investigational devices are subject to modified quality system requirements, as specified in FDA regulations.

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