QMSR Explained: What FDA’s New Quality Management System Regulation Means for Medical Device Manufacturers

By Linda M. Chatwin, Esq., RAC, lead regulatory and quality consultant, Emergo by UL

Background

On Feb. 2, 2026, the U.S. Food and Drug Administration (FDA) began enforcing the Quality Management System Regulation (QMSR), fundamentally changing how medical device quality system requirements are structured in the United States. The regulation incorporates ISO 13485:2016 into Title 21 of the Code of Federal Regulations (CFR) Part 820 and aligns the FDA’s quality system framework more closely with the one used by regulators around the world.

For manufacturers, the QMSR is not simply a regulatory update. It is a significant harmonization initiative intended to reduce differences between U.S. and international quality management system (QMS) requirements while preserving FDA-specific obligations.

The key message is straightforward: ISO 13485 is now the foundation of FDA QMS compliance, but it is not the only requirement (FDA final rule on the Quality System Regulation amendments).

Why the QMSR matters

The FDA’s objective was to modernize and harmonize its medical device quality system requirements with the international standard already used by many manufacturers and regulators worldwide. By incorporating ISO 13485:2016 by reference, the FDA has reduced duplication between U.S. and international QMS requirements while retaining provisions necessary to support FDA oversight and public health objectives.

For global manufacturers, this alignment may simplify QMS management and reduce the need to maintain separate compliance frameworks for U.S. and non-U.S. markets. However, organizations should not assume that ISO 13485 certification alone demonstrates FDA compliance (FDA QMSR frequently asked questions).

What changed?

The revised Part 820 is considerably shorter than the former Quality System Regulation (QSR) because most QMS requirements are now incorporated through ISO 13485:2016. The FDA retained only a limited number of supplemental provisions within the regulation itself.

The QMSR now consists primarily of:

• Requirements for a QMS based on ISO 13485:2016
• Supplemental FDA requirements for records
• Supplemental FDA requirements for labeling and packaging controls

These supplemental provisions represent the main FDA-specific additions to the ISO 13485 framework (FDA Quality Management System Regulation overview).

Which ISO 13485 requirements are included?

The QMSR incorporates the core elements of ISO 13485:2016, including requirements related to:

• QMS scope and organization
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement

These areas encompass the activities associated with an effective QMS, including design and development, supplier management, production controls, complaint handling, internal audits, corrective actions, and management review. In practical terms, organizations familiar with ISO 13485 will recognize that the standard now serves as the primary framework for FDA QMS compliance.

What requirements did the FDA retain?

Although the FDA adopted ISO 13485 as the basis of the QMSR, the agency determined that certain requirements needed to remain within Part 820 to support existing FDA regulatory programs.

Control of records (Section 820.35)

The FDA retained specific recordkeeping requirements related to:

• Complaint investigations
• Servicing activities
• Unique device identification (UDI)
• Information needed to support other FDA regulatory requirements

These provisions extend beyond the general record-control requirements contained within ISO 13485.

Device labeling and packaging controls (Section 820.45)

The FDA also retained controls for labeling and packaging operations because the agency concluded that ISO 13485 does not specifically address certain labeling inspection activities. These requirements focus on preventing labeling errors, mix-ups and distribution-related issues.

A common misconception

A common misconception surrounding the QMSR is the belief that ISO 13485 certification automatically satisfies FDA requirements.

The FDA has explicitly stated that this is not the case. While ISO 13485 forms the foundation of the regulation, manufacturers must also comply with the supplemental requirements contained within Part 820 and with other applicable FDA regulations, including Medical Device Reporting (MDR), UDI requirements, and corrections and removals requirements.

An ISO 13485 certificate may demonstrate conformity to the standard, but it does not replace FDA compliance obligations or exempt a manufacturer from FDA inspections (FDA QMSR frequently asked questions, Question 13).

Concluding remarks

The QMSR is best viewed as a harmonization initiative rather than an entirely new regulatory framework.

For most manufacturers, the QMS processes themselves will remain familiar. The strategic challenge is maintaining existing ISO 13485-based systems that adequately address the FDA-specific requirements that remain within Part 820 and throughout the broader FDA regulatory framework.

Organizations that approach the QMSR as "ISO 13485 plus FDA-specific requirements" may be better positioned to manage compliance, prepare for inspections and benefit from greater global alignment.

Our next feature in this series will be a detailed review of the FDA’s updated inspection program and how QMSR inspections differ from traditional Quality System Inspection Technique (QSIT) inspections, ISO 13485 audits and Medical Device Single Audit Program (MDSAP) audits.