Published: 26th October 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is the FDA Quality Management System Regulation (QMSR)?
The FDA Quality Management System Regulation, commonly referred to as QMSR, is the quality management system framework that now applies to medical device manufacturers subject to the requirements of 21 CFR Part 820.
QMSR became effective on 2 February 2026, replacing the previous Quality System Regulation framework and aligning FDA’s medical device quality system requirements more closely with the internationally recognised ISO 13485 standard.
One of the most significant changes is that FDA has incorporated by reference:
- ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
- Clause 3 of ISO 9000:2015, covering quality management terminology and definitions.
For manufacturers already operating an ISO 13485 quality management system, this creates significantly greater alignment between US and international quality requirements.
However, it does not mean that ISO 13485 certification automatically demonstrates complete FDA compliance.
Manufacturers still need to understand and implement the FDA-specific requirements that sit alongside the incorporated ISO standard.
Understanding FDA QMSR and ISO 13485 Requirements?
The FDA Quality Management System Regulation (QMSR), which came into effect on 2 February 2026, represents a significant change to US medical device quality management requirements. Replacing the former Quality System Regulation (QSR) framework under 21 CFR Part 820, QMSR incorporates ISO 13485:2016 by reference, bringing FDA quality system requirements into closer alignment with international standards. However, manufacturers must still address additional FDA-specific regulatory obligations, including applicable requirements relating to records, labelling, Unique Device Identification (UDI) and post-market compliance. Understanding how QMSR relates to ISO 13485 is essential for manufacturers supplying the US market. For a broader overview of FDA compliance, read our Complete Guide to FDA Medical Device Regulations for Manufacturers.
When Did FDA QMSR Become Effective?
FDA published the final Quality System Regulation amendment on 2 February 2024.
Manufacturers were provided with a two-year transition period.
QMSR then became effective on:
2 February 2026
As of that date, medical device manufacturers subject to the regulation are expected to comply with the new QMSR requirements.
This means manufacturers entering the US market in 2026 should no longer be developing their FDA quality systems around the old Quality System Regulation.
Their quality management system should be assessed against the current QMSR framework.
Why Did FDA Introduce QMSR?
The previous FDA Quality System Regulation and ISO 13485 already contained many similar quality management principles.
However, manufacturers supplying both the United States and international markets frequently had to maintain systems that addressed two separate regulatory structures.
FDA introduced QMSR to align its requirements more closely with the internationally recognised medical device quality management system standard.
FDA has stated that ISO 13485’s requirements, taken as a whole, are substantially similar to those of the previous Quality System Regulation and provide a similar level of assurance regarding a manufacturer’s ability to consistently produce safe and effective medical devices.
Greater alignment should make it easier for manufacturers to operate a single global quality management system while still meeting jurisdiction-specific regulatory requirements.
Does QMSR Replace 21 CFR Part 820?
No.
This is an important distinction.
QMSR does not eliminate 21 CFR Part 820.
Instead, FDA amended Part 820 and renamed the revised regulation the Quality Management System Regulation.
The new Part 820 incorporates ISO 13485:2016 by reference while retaining and adding FDA-specific provisions.
The revised structure includes provisions covering areas such as:
- Scope
- Definitions
- Incorporation by reference
- Quality management system requirements
- Control of records
- Device labelling and packaging controls
FDA therefore continues to regulate medical device quality systems through federal regulation.
ISO 13485 is now incorporated into that regulatory framework.
How Does ISO 13485:2016 Fit into FDA QMSR?
ISO 13485:2016 establishes requirements for a quality management system where an organisation needs to demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.
Under QMSR, FDA incorporates ISO 13485:2016 by reference.
This brings areas such as the following into the FDA quality management framework:
- Quality management system documentation
- Management responsibility
- Resource management
- Product realisation
- Design and development
- Purchasing and supplier controls
- Production and service provision
- Monitoring and measurement
- Complaint handling
- Nonconforming product
- Corrective and preventive action
- Internal auditing
- Management review
- Risk-based processes
For manufacturers already certified to ISO 13485:2016, much of this framework should therefore already be familiar.
But ISO certification and FDA regulatory compliance remain two different things.
What Is ISO 13485 and Why Is It Important for FDA QMSR?
ISO 13485:2016 is the internationally recognised quality management system standard for medical device manufacturers and organisations involved in the medical device lifecycle. With the FDA Quality Management System Regulation (QMSR) incorporating ISO 13485:2016 by reference from 2 February 2026, understanding the standard is increasingly important for manufacturers entering or operating in the US market. ISO 13485 establishes requirements for quality management systems covering design and development, production, risk management, supplier controls and regulatory compliance. However, compliance with ISO 13485 alone does not automatically demonstrate full compliance with all FDA requirements. To understand the standard, its key requirements and how it supports medical device regulatory compliance, read our Complete Guide to ISO 13485 for Medical Device Manufacturers.
Does ISO 13485 Certification Mean You Comply With FDA QMSR?
No.
An ISO 13485 certificate can provide strong evidence that a manufacturer operates an established medical device quality management system.
It does not, by itself, establish compliance with all FDA requirements.
FDA remains the regulator for medical devices placed on the US market.
Manufacturers need to consider:
ISO 13485 requirements
plus
FDA-specific QMSR provisions
plus
other applicable FDA regulations.
This distinction is particularly important for UK and EU manufacturers that already hold ISO 13485 certification.
Their existing QMS can provide an excellent foundation, but an FDA/QMSR gap assessment should still be performed.
How Did FDA QSR Differ from ISO 13485?
Before the introduction of the FDA Quality Management System Regulation (QMSR) on 2 February 2026, medical device manufacturers supplying the US market were required to comply with the FDA Quality System Regulation (QSR) under 21 CFR Part 820. Although QSR and ISO 13485 shared many quality management principles, important differences existed in areas such as documentation, management responsibilities, design controls and regulatory requirements. The transition to QMSR has brought US quality system requirements into closer alignment with ISO 13485:2016, while retaining additional FDA-specific obligations. To understand the historical differences and how the regulatory framework has evolved, read our 5 Key Differences Between ISO 13485 and the FDA Quality System Regulation (QSR).
What FDA-Specific Requirements Remain Under QMSR?
Although QMSR incorporates ISO 13485, FDA has retained additional provisions necessary to align the quality management system with US law.
The revised Part 820 therefore needs to be read together with the incorporated ISO requirements.
Particular attention should be given to FDA requirements concerning areas such as:
- Records
- Complaint records
- Servicing records where applicable
- Unique Device Identification information within applicable records
- Device labelling
- Device packaging
- FDA terminology and definitions
- Other records required under applicable FDA regulations
Manufacturers also need to remember that QMSR does not operate in isolation.
Other FDA requirements can apply alongside Part 820, including requirements concerning Medical Device Reporting, corrections and removals, registration, listing and UDI.
An FDA-compliant QMS therefore needs to integrate these wider regulatory obligations into the organisation’s processes.
What Does QMSR Mean for Risk Management?
Risk has an important role within the QMSR framework.
ISO 13485 contains risk-based requirements throughout the quality management system, and FDA has specifically addressed risk management and risk-based decision-making as part of its QMSR implementation programme.
For manufacturers, this means risk should not be treated as a document produced once during product development.
Risk-based thinking can influence:
- Design and development
- Supplier controls
- Production controls
- Verification and validation
- Complaint investigation
- CAPA
- Change control
- Post-market activities
For medical device manufacturers, ISO 14971 risk management will therefore remain an important part of the wider quality and regulatory framework.
What Does QMSR Mean for Design and Development?
Design controls have not disappeared.
QMSR incorporates the design and development requirements in Clause 7.3 of ISO 13485:2016.
FDA has specifically confirmed that the QMSR incorporates ISO 13485 Clause 7.3 and its subclauses for design and development.
Manufacturers therefore need controlled processes addressing areas such as:
- Design and development planning
- Design inputs
- Design outputs
- Design review
- Design verification
- Design validation
- Design transfer
- Design changes
- Design and development records
The terminology may look different from the previous FDA Quality System Regulation, but the need for a robust, documented development process remains.
What Happened to the Design History File?
Manufacturers familiar with the previous FDA Quality System Regulation will recognise terms such as:
DHF – Design History File
Under QMSR, some of the terminology used in the old regulation no longer appears in the same form.
FDA has specifically noted that QMSR does not use certain former terms such as “Design History File” and “Design Change.”
The underlying requirements are instead addressed through ISO 13485:2016 Clause 7.3 and its subclauses.
This does not mean manufacturers can stop maintaining design and development evidence.
Rather, manufacturers should ensure their QMS terminology and records map correctly to the current QMSR and ISO 13485 requirements.
What Does QMSR Mean for CAPA?
Corrective and preventive action remains a fundamental component of an effective medical device quality management system.
Under the ISO 13485 framework incorporated into QMSR, manufacturers need processes for identifying and addressing quality problems, investigating causes and implementing appropriate corrective action.
A functioning CAPA system should connect information from sources such as:
- Complaints
- Nonconformities
- Internal audits
- Supplier issues
- Production problems
- Post-market information
- Trend analysis
- Regulatory findings
The effectiveness of corrective actions should also be evaluated.
QMSR should therefore not be viewed as reducing the importance of CAPA simply because the structure and terminology of Part 820 have changed.
What Does QMSR Mean for Supplier Controls?
Manufacturers remain responsible for controlling outsourced processes, products and services that can affect device quality.
A QMSR-ready supplier control system should therefore consider:
- Supplier selection
- Supplier evaluation
- Qualification criteria
- Risk-based supplier controls
- Purchasing information
- Monitoring supplier performance
- Supplier re-evaluation
- Supplier corrective action
- Records of supplier controls
The extent of control should reflect the potential effect of the supplied product or service on the finished medical device.
For UK and EU manufacturers already operating an ISO 13485-certified QMS, these processes may already be established but should still be assessed against FDA expectations.
FDA QMSR and Complaint Handling
Complaint handling remains particularly important under FDA regulation.
FDA’s QMSR page specifically notes that even manufacturers of finished devices exempt from CGMP requirements are not exempt from maintaining complaint files or from applicable general record requirements under 21 CFR 820.35.
Complaint processes need to support appropriate assessment of whether an event may also trigger other FDA obligations.
For example, complaints may need to be assessed for:
- Medical Device Reporting
- Corrective and preventive action
- Corrections and removals
- Risk management updates
- Trend analysis
- Regulatory reporting
Complaint handling should therefore be connected to the manufacturer’s wider post-market surveillance and vigilance processes.
How Have FDA Medical Device Inspections Changed?
One of the biggest practical changes in 2026 concerns FDA inspections.
On 2 February 2026, FDA stopped using the Quality System Inspection Technique (QSIT) for medical device inspections.
FDA now uses the inspection process described in its updated:
Inspection of Medical Device Manufacturers Compliance Program – CP 7382.850.
The new process aligns FDA inspections with QMSR.
This is particularly important for manufacturers that have previously prepared for FDA inspections using the old QSIT model.
Can FDA Inspect Your Internal Audit and Management Review Records?
Yes.
This is a particularly important change for manufacturers.
Under the previous Quality System Regulation, certain records were protected from routine FDA inspection under former §820.180(c).
FDA states that those exceptions have not been retained under QMSR.
FDA therefore has authority to inspect records including:
- Management review reports
- Quality audit reports
- Supplier audit reports.
Manufacturers should make sure these records are complete, controlled and capable of demonstrating that their quality management system is functioning effectively.
This makes the quality of internal auditing and management review documentation even more important under the new FDA framework.
Does an ISO 13485 Audit Replace an FDA Inspection?
No.
An audit by an ISO 13485 certification body and an FDA regulatory inspection are not the same thing.
ISO 13485 certification can demonstrate conformity with the certification requirements assessed by the certification body.
FDA retains its regulatory inspection and enforcement authority.
FDA advises manufacturers preparing for an inspection after 2 February 2026 to be ready to discuss and provide records demonstrating compliance with QMSR.
Manufacturers should therefore not assume that successfully passing an ISO 13485 surveillance or certification audit means they are automatically prepared for an FDA inspection.
What Should Manufacturers Expect During a QMSR Inspection?
FDA’s updated inspection programme is intended to assess compliance with QMSR and applicable requirements of the Federal Food, Drug, and Cosmetic Act.
Manufacturers should be prepared to demonstrate that their quality management system is not merely documented but effectively implemented.
This can include evidence concerning:
- Management responsibility
- Risk-based processes
- Design and development
- Supplier controls
- Production and process controls
- Complaint handling
- CAPA
- Internal auditing
- Management review
- Records
- Labelling and packaging controls
FDA’s updated Compliance Program CP 7382.850 describes the current QMSR inspection process.
What Does QMSR Mean for UK and EU Manufacturers?
For UK and EU medical device manufacturers, the move to QMSR represents an important opportunity.
Many manufacturers already operate a QMS based on ISO 13485:2016 to support:
- EU MDR
- EU IVDR
- UK MDR
- Notified Body certification
- Approved Body certification
Because FDA now incorporates ISO 13485:2016 into QMSR, the foundations of the manufacturer’s existing QMS may align more closely with US requirements than under the previous FDA framework.
However, there are still differences.
A manufacturer should therefore avoid assuming:
ISO 13485 certified = FDA compliant.
Instead, the existing QMS should be mapped against QMSR and other applicable FDA requirements.
Do UK and EU Manufacturers Need a Completely New QMS for FDA?
Usually, no.
For an organisation already operating a mature ISO 13485 quality management system, creating a completely separate FDA QMS would often introduce unnecessary duplication.
A more practical approach is normally to operate an integrated quality management system that addresses:
ISO 13485 + FDA QMSR + applicable market-specific requirements.
The organisation can then maintain common processes for areas such as document control, CAPA, complaints, supplier management, risk management and internal auditing while incorporating jurisdiction-specific requirements where necessary.
This can make maintaining compliance across multiple markets significantly more manageable.
How to Perform an FDA QMSR Gap Assessment
For an ISO 13485-certified manufacturer entering the United States, a structured QMSR gap assessment is a sensible starting point.
The assessment should consider:
- Existing ISO 13485 procedures
- Current quality manual and QMS structure
- FDA-specific Part 820 requirements
- FDA terminology
- Record requirements
- Labelling and packaging controls
- Complaint handling
- Medical Device Reporting interfaces
- Corrections and removals
- UDI requirements
- Registration and listing interfaces
- FDA inspection readiness
- Internal audit coverage
- Management review
- Training requirements
The outcome should be a documented action plan identifying:
Requirement → Current Control → Gap → Required Action → Responsibility → Completion
This gives the manufacturer a structured route from ISO 13485 conformity to FDA QMSR readiness.
Common FDA QMSR Compliance Mistakes
Some of the most likely problems for manufacturers transitioning to or implementing QMSR include:
- Assuming ISO 13485 certification automatically establishes FDA compliance
- Continuing to use an old 21 CFR Part 820 checklist without updating it for QMSR
- Preparing for inspections using QSIT
- Failing to map FDA-specific requirements into the QMS
- Treating risk management as a standalone technical-file activity
- Weak supplier controls
- Inadequate complaint-to-MDR escalation
- Poor CAPA investigations
- Incomplete internal audit records
- Weak management review records
- Failing to prepare audit and management review records for potential FDA inspection
- Maintaining separate ISO and FDA systems unnecessarily
- Failing to train personnel on the new QMSR framework
By October 2026, manufacturers should be operating against the current QMSR, rather than treating it as an upcoming regulatory change.
How Patient Guard Can Support FDA QMSR Compliance
Patient Guard can support manufacturers preparing for or maintaining FDA QMSR compliance through:
- FDA QMSR gap assessments
- ISO 13485 implementation
- Integrated ISO 13485/QMSR quality systems
- Quality manual and procedure development
- FDA-specific procedure development
- Risk management
- CAPA systems
- Supplier controls
- Complaint handling
- Internal audits
- Management review support
- FDA inspection readiness assessments
- FDA regulatory strategy
- 510(k) quality system support
For manufacturers already certified to ISO 13485, we can assess the existing QMS and identify the additional controls required for FDA compliance rather than unnecessarily rebuilding the quality system from the beginning.
Preparing Your Quality Management System for FDA in 2026
The introduction of QMSR represents one of the most significant changes to FDA medical device quality system regulation in decades.
For manufacturers already working to ISO 13485:2016, the increased alignment is positive.
But harmonisation should not be confused with equivalence.
Manufacturers still need to understand FDA-specific requirements, integrate them into their quality management system and prepare for FDA’s new inspection approach.
The most efficient route for many UK and EU manufacturers is therefore:
Existing ISO 13485 QMS → QMSR Gap Assessment → FDA-Specific Updates → Internal Audit → Inspection Readiness
That allows manufacturers to build on an existing international quality system while establishing a robust framework for ongoing compliance in the United States.
Frequently Asked Questions About FDA QMSR
QMSR stands for Quality Management System Regulation. It is the revised FDA medical device quality management framework contained in 21 CFR Part 820.
QMSR became effective on 2 February 2026.
Yes. QMSR incorporates ISO 13485:2016 by reference. It also incorporates Clause 3 of ISO 9000:2015 concerning terminology.
No. ISO 13485 provides much of the underlying quality management framework, but manufacturers must also meet applicable FDA-specific requirements.
No. FDA amended 21 CFR Part 820 and renamed it the Quality Management System Regulation. ISO 13485:2016 is incorporated by reference within the FDA regulatory framework.
No. FDA stopped using QSIT on 2 February 2026 and now uses the inspection process described in Compliance Program CP 7382.850.
Yes. FDA confirms that the previous exceptions were not maintained under QMSR, meaning FDA has authority to inspect management review, quality audit and supplier audit reports.
Not necessarily. An integrated QMS can be designed to meet ISO 13485, QMSR and other applicable regulatory requirements.
References
This guide is based on official U.S. Food and Drug Administration (FDA) regulatory information, federal regulations and guidance relating to the Quality Management System Regulation (QMSR) and its relationship with ISO 13485:2016. References cover the replacement of the former Quality System Regulation (QSR), the incorporation of ISO 13485 into 21 CFR Part 820, additional FDA-specific requirements, quality management system compliance and the updated FDA medical device inspection framework introduced on 2 February 2026.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| U.S. Food and Drug Administration (FDA) | Quality Management System Regulation (QMSR) | The FDA's principal resource explaining the QMSR, its implementation on 2 February 2026 and the incorporation of ISO 13485:2016 by reference. Covers applicability, regulatory requirements, harmonisation and the revised inspection framework. |
| Electronic Code of Federal Regulations (eCFR) | 21 CFR Part 820 - Quality Management System Regulation | Provides the current regulatory text governing FDA medical device quality management systems, including incorporation by reference, applicable QMS requirements, record controls and device labelling and packaging controls. |
| U.S. Food and Drug Administration (FDA) | QMSR Frequently Asked Questions | Addresses common questions about QMSR implementation, ISO 13485 incorporation, FDA inspections, access to standards, regulatory compliance and the relationship between ISO 13485 certification and FDA requirements. |
| U.S. Food and Drug Administration (FDA) | Quality and Compliance (Medical Devices) | Provides an overview of FDA medical device quality and compliance obligations, including the QMSR, current good manufacturing practice requirements and quality system regulatory oversight. |
| Electronic Code of Federal Regulations (eCFR) | 21 CFR 820.10 - Requirements for a Quality Management System | Establishes requirements for manufacturers to document a QMS complying with applicable ISO 13485 requirements and additional FDA regulations. Includes provisions relating to identification, traceability and other applicable US regulatory obligations. |
| U.S. Food and Drug Administration (FDA) | CDRH Compliance Programs - Medical Device Inspections | Provides access to FDA inspection compliance programmes, including Compliance Program 7382.850. Explains the inspection framework introduced alongside QMSR, replacing the former Quality System Inspection Technique (QSIT). |
| U.S. Food and Drug Administration (FDA) | FDA QMSR Risk-Based Inspections - Industry Town Hall | Provides FDA educational materials explaining the revised medical device inspection process under QMSR, including risk-based inspections and implementation of Compliance Program 7382.850. |
| U.S. Food and Drug Administration (FDA) | Computer Software Assurance for Production and QMS Software | FDA guidance describing a risk-based approach to assuring software used in medical device production and quality management systems, supporting implementation of applicable QMSR requirements. |
| U.S. Government Publishing Office | Historical 21 CFR Part 820 - Former Quality System Regulation | Provides the previous FDA Quality System Regulation as published before QMSR implementation. Useful for understanding the historical differences between FDA QSR and ISO 13485 and how the US regulatory framework has evolved. |
The FDA Quality Management System Regulation (QMSR) became effective on 2 February 2026, replacing the former Quality System Regulation framework under 21 CFR Part 820. QMSR incorporates ISO 13485:2016 by reference, bringing US medical device quality management requirements into closer alignment with internationally recognised standards. However, ISO 13485 certification alone does not establish full compliance with FDA regulatory requirements or exempt a manufacturer from FDA inspections. Manufacturers must also comply with applicable FDA-specific requirements, including relevant provisions relating to records, labelling, Unique Device Identification (UDI), medical device reporting and other post-market obligations. Manufacturers should review the current regulatory requirements and official FDA guidance when establishing, implementing or maintaining their quality management systems.
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