Update: FDA Adopts International Standards for Medical Device Quality Management
TL/DR –
The Quality Management System Regulation (QMSR) becomes effective on February 2, 2026, incorporating international medical device quality management systems standards set by the International Organization for Standardization (ISO), specifically ISO 13485:2016. The new QMSR applies to finished device manufacturers who aim to commercially distribute medical devices and will align U.S. medical device quality management system requirements with internationally recognized standards. Existing documents for inspections, including the Quality System Inspection Technique (QSIT), will be discontinued and replaced by the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850.
Quality Management System Regulation (QMSR) Update
As of February 2, 2026, the Quality Management System Regulation (QMSR) became effective. It amends the device Current Good Manufacturing Practice (CGMP) requirements of 21 CFR Part 820, incorporating the ISO 13485:2016 specific for medical device quality management systems set by the International Organization for Standardization (ISO). This harmonizes the FDA’s CGMP regulatory framework with other regulatory authorities.
Introduction to QMSR
To ensure products meet requirements and specifications, manufacturers must follow the QMSR. The quality management systems for FDA-regulated products are known as CGMP’s. The CGMP requirements for devices in part 820 were first authorized by the FD&C Act. After extensive revision, the FDA issued the Medical Devices; Quality System Regulation Amendments Final Rule to amend the device CGMP requirements of 21 CFR part 820. The rule was effective February 2, 2026, under the title Quality Management System Regulation (QMSR).
Applicability of the QMSR
The QMSR applies to manufacturers who intend to commercially distribute medical devices. A finished device is any device or accessory suitable for use or capable of functioning, whether or not it is packaged or sterilized. Certain components such as blood tubing and diagnostic x-ray components are considered finished devices because they are accessories to finished devices, making their manufacturers subject to the QMSR.
Incorporation By Reference
The QMSR incorporates ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes and clause 3 of ISO 9000:2015, Quality management systems – Fundamentals and vocabulary, allowing U.S. medical device quality management system requirements to align with internationally recognized standards. This promotes consistency in design, production, and lifecycle controls across global markets and requires risk management.
CGMP Exemptions
The FDA determined that certain types of medical devices are exempt from CGMP requirements. However, exemption from the CGMP requirements does not exempt manufacturers of finished devices from keeping complaint files or from general records requirements. Medical devices manufactured under an investigational device exemption are not exempt from design and development requirements under the QMSR and the requirements in ISO 13485.
QMSR Inspections
From February 2, 2026, the FDA began aligning its inspection process with the requirements of the QMSR, using the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850.
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