Quality Management System Regulation (QMSR)

Update: February 2, 2026

The Quality Management System Regulation (QMSR) that became effective on February 2, 2026, amends the device current good manufacturing practice (CGMP) requirements of 21 CFR Part 820, incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. This action harmonizes the FDA’s CGMP regulatory framework with that used by other regulatory authorities.

On February 2, 2026, the FDA began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. After February 2, 2026, the FDA will no longer use the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001).

Introduction
Applicability of the QMSR Regulation
Incorporation By Reference (IBR)
CGMP Exemptions
QMSR Inspections
QMSR Resources

Introduction

Manufacturers must establish and follow the Quality Management System Regulation (QMSR) to help ensure that their products consistently meet applicable requirements and specifications. The quality management systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 520(f) of the FD&C Act, the FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820.

In 1990, the FDA undertook the start of the revision of the CGMP regulation to add the design controls authorized by the Safe Medical Devices Act. Also, the agency believed that it would be beneficial to the public and the medical device industry for the CGMP regulation to be consistent, to the extent possible, with the requirements for quality systems contained in applicable international standards, primarily, the International Organization for Standardization (ISO) 9001:1994 "Quality Systems--Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” and at the time the ISO committee draft (CD) revision of ISO/CD 13485 "Quality Systems--Medical Devices--Supplementary Requirements to ISO 9001.” After an extensive effort, the part 820 revision was published on October 7, 1996 (61 FR 52602) and went into effect June 1, 1997.

The FDA issued the Medical Devices; Quality System Regulation Amendments Final Rule to amend the device CGMP requirements of 21 CFR part 820 to harmonize and modernize the regulation. The FDA is incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

The rule is effective February 2, 2026, and is now titled Quality Management System Regulation (QMSR).

Applicability of the QMSR

The QMSR regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(a) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Certain components such as blood tubing and diagnostic x-ray components are considered by the FDA to be finished devices because they are accessories to finished devices. A manufacturer of accessories is subject to the QMSR.

Incorporation By Reference (IBR)

The QMSR incorporates by reference the international standard, 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. This allows U.S. medical device quality management system requirements to align with internationally recognized standards and reduce burden on regulated industry.

Incorporating by reference ISO 13485:2016 as the foundational quality management system framework for medical device manufacturers promotes consistency in design, production, and lifecycle controls across global markets and now specifically requires risk management.

Incorporating by reference the terms and definitions set forth in Clause 3 of ISO 9000:2015 supports a common understanding of quality management system fundamentals. However, to the extent any clause of ISO 13485 conflicts with any provision of the FD&C Act and its implementing regulations, the FD&C Act and/or its implementing regulations will control. This ensures that public health protections, regulatory expectations, and enforcement authorities under the FD&C Act remain fully intact.

CGMP Exemptions

The FDA has determined that certain types of medical devices are exempt from current good manufacturing practices (CGMP) requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the CGMP requirements does not exempt manufacturers of finished devices from keeping complaint files or from general requirements concerning records required by 21 CFR 820.35.

Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design and development requirements under 21 CFR 820.10(c) of the QMSR and the requirements in ISO 13485, Design and Development, Clause 7 and its subclauses.

QMSR Inspections

The FDA has a new inspection process that aligns with the requirements of the Quality Management System Regulation (QMSR). On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. On February 2, 2026, the FDA stopped using the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001).