FDA QMSR Overview
In this lesson, we present an overview of the Quality Management System Regulation. This regulation is part of the Final Rule titled “Medical Devices; Quality System Regulation Amendments,” issued by FDA. We'll use both terms, as well as “2024 Final Rule,” throughout this lesson.
There are many great quotes about quality. This one fits good quality management systems for medical devices: quality is never an accident; it is always the result of intelligent effort. The same can be said for the Quality Management System Regulation. As you'll learn, it is both intentional and intelligent, and its construct makes it easier to have a single, harmonized quality management system in a global landscape.
FDA developed two modules to help you understand the Quality Management System Regulation, or QMSR. Part 1 provides an overview of the Final Rule. Part 2 walks through and navigates some of the details of the QMSR. This series adds a third lesson on risk management, based on a later FDA module.
Here are the learning objectives. First, discuss the Final Rule, including its preamble. Then, provide an overview of the Quality Management System Regulation. Third, identify some important definitions and their hierarchy of application. And finally, review some FDA activities to implement the rule.
The 2024 Final Rule
On February 2nd, 2024, FDA published the Final Rule, titled “Medical Devices; Quality System Regulation Amendments,” in the Federal Register. FDA encourages you to read the rule; a printable PDF version is also available.
Prior to issuing the Final Rule, FDA issued a Proposed Rule. Its purpose was to notify the public of FDA's intent to issue this regulation and to solicit public comment.
The 2024 Final Rule explains FDA's final regulatory framework, including background on how the public was engaged in the rulemaking process and why this regulation was needed. The preamble of the Final Rule summarizes 83 public comments that FDA received on the Proposed Rule, and FDA's responses to those comments. Reading the preamble is strongly encouraged, because it provides useful insight, context and understanding into FDA's thinking and intent in issuing the 2024 Final Rule.
From the QS regulation to the QMSR
The 2024 Final Rule revises the Quality System Regulation that was published in October 1996. That regulation was established in Title 21 of the Code of Federal Regulations, or CFR, Part 820. FDA refers to the 1996 regulation as the QS regulation.
The 2024 Final Rule revises Part 820, including its title, which is renamed the Quality Management System Regulation. The Final Rule further harmonizes quality system principles by converging its requirements with international efforts and principles, including current thinking regarding risk. A harmonized rule makes it easier for global manufacturers to have a single quality management system that efficiently meets global regulatory requirements.
The transition period from the 1996 Quality System Regulation to the 2024 Quality Management System Regulation is two years. The QMSR effective date is February 2nd, 2026. From that date, all manufacturers that market medical devices in the US must comply with the QMSR.
What the QMSR keeps
Now for a brief, high-level overview of the Quality Management System Regulation.
As you read through the QMSR, you'll find that most of the requirements from the 1996 QS regulation have been revised. However, the 2024 QMSR retains the scope and some of the definitions from the 1996 QS regulation.
From the scope, you'll find that you still decide the needs of your quality management system. You still have the flexibility to use factors such as your device, the risk of your device, its complexity, your manufacturing processes, the risk those processes pose to your device and their complexity, and the size and makeup of your company when documenting your quality management system.
The regulation also includes conforming edits to Part 4 for combination products, and the change does not affect the cGMP requirements for combination products.
How the regulation is organized
Here is the outline of the new regulation. Get used to the new format of the QMSR, and become familiar with the structure of the ISO 13485:2016 standard.
The scope and definitions are in 820.1 and 820.3. They are followed by the incorporation by reference section, 820.7. Next come the requirements for a quality management system in 820.10, control of records in 820.35, and device labeling and packaging controls in 820.45. These requirements are explained further in Part 2, Navigating the Quality Management System Regulation.
Note that the regulation includes some numbers that are reserved. These sections are identified but had no details when the 2024 Final Rule was published. FDA may provide details in these sections in the future.
Standards incorporated by reference
To keep things as simple as possible, FDA incorporated ISO 13485:2016 by reference. This is not a transition to, or adoption of, the standard. It is an incorporation by reference of called-out provisions, to ensure consistency with applicable FDA requirements, including definitions.
ISO 13485 also has a normative reference, which FDA incorporated by reference into the regulation: ISO 9000:2015, Quality management systems, Fundamentals and vocabulary, clause 3. It contains terms and definitions necessary for the application of ISO 13485.
Where can you find these standards? Read-only versions are available through a link in the Final Rule. You can also purchase copies of the standards from the American National Standards Institute, or ANSI.
What happens when the ISO 13485:2016 standard is updated? Any future changes to the standards will need to be evaluated, and if needed, those changes will need to be addressed through further rulemaking.
A hierarchy of definitions
Next, let's discuss definitions. It's important to understand how the different definitions are laid out and their hierarchy. A flow chart shows how these definitions are linked to one another.
At the top of the hierarchy is the Federal Food, Drug, and Cosmetic Act, or FD&C Act: the law. Section 201 of the FD&C Act has definitions that affect the QMSR, such as section 201(h), the definition of a medical device.
Next in the hierarchy, below the law, is the regulation and the definitions within it, in section 820.3 of the QMSR. The regulation also explains which definitions supersede those in the standard, and which terms are not defined in the standard but are defined by FDA.
Last, completing the flow chart, are the definitions in the standards themselves: the terms and definitions in clause 3 of ISO 13485:2016, and then those in clause 3 of ISO 9000:2015. These definitions, like the standards themselves, are incorporated by reference.
Superseding and FDA-specific terms
The QMSR identifies which definitions supersede the definitions found in the standards. These superseding definitions include all of those in section 201 of the FD&C Act, such as the definitions of a medical device and labeling.
They also include terms defined in the Code of Federal Regulations, such as implantable medical device, and terms defined in the QMSR itself, such as manufacturer, organization and rework. Notably, the QMSR uses the phrase safety and performance instead of safety and effectiveness, and defines safety and performance to have the meaning of safety and effectiveness.
Finally, some terms are not in the standards and are included in the QMSR. These terms are specific to FDA. They include the Federal Food, Drug, and Cosmetic Act; component; finished device; human cell, tissue, or cellular or tissue-based product regulated as a device; and remanufacturer.
How FDA is implementing the rule
Let's wrap up the overview with the activities FDA described for implementing the 2024 Final Rule.
Start with FDA inspections. FDA retains its inspectional authority. As a result of an inspection, FDA will not issue certificates of conformance to ISO 13485:2016, and manufacturers that hold a certificate of conformance to ISO 13485:2016 are not exempt from FDA inspections. Keep in mind that FDA will not require ISO 13485 certificates.
Implementing the rule also involves updating various FDA technological systems, and revising and developing relevant policies, procedures, the inspection process and other documents affected by this rulemaking. These include the compliance program guide, guidance documents, standard operating procedures and work instructions.
FDA also described training its own personnel on the 2024 Final Rule, issuing public communications, and conducting external education, like the CDRH Learn module this lesson is based on.
Summary and next steps
To summarize, FDA has issued the 2024 Final Rule, titled “Medical Devices; Quality System Regulation Amendments,” which includes a preamble. The preamble provides background on FDA's review of public comments and the thinking that led to the rule. The Final Rule also includes the QMSR. The QMSR incorporates by reference two standards: ISO 13485:2016, and clause 3 of ISO 9000:2015. The 2024 Final Rule and the QMSR include a hierarchy of definitions. And finally, FDA carries out various activities to implement the rule, and it retains its inspection authority.
Here is your call to action. Read the 2024 Final Rule, including the preamble. Review the QMSR, and use the available educational resources to help you implement it. Then continue with Part 2 of this series, Navigating the Quality Management System Regulation.
This lesson began with a quote on quality, and it ends with one on success: success is the sum of small efforts, repeated day in and day out. Every day, work is done in your quality management system. Quality matters, and it affects the devices that are developed and manufactured. That requires daily effort, including understanding regulatory requirements for quality.
This lesson draws on the FDA CDRH Learn presentation “An Overview of the Quality Management System Regulation,” published in September 2024. It is introductory education, not an official FDA course. Applicable regulations and your company's approved procedures govern actual work.
SOURCE CREDIT FDA CDRH Learn, “An Overview of the Quality Management System Regulation” (YouTube, 23 September 2024); narration adapted from FDA's presentation transcript. This video re-presents FDA's educational content with a new narrator and original graphics. It is not an official FDA course. Applicable regulations and company procedures govern actual work.