The focus is on the FDA's harmonization of 21 CFR part 820, better known as QSR (Quality System Regulation), with ISO 13485:2016. QSR, which currently contains cGMP (Current Good Manufacturing Practices) requirements for manufacturers of medical devices, is now undergoing a transformation that involves not only a technical adjustment but also a name change. The new name, QMSR (Quality Management System Regulation), will become binding on February 2, 2026, after a two-year transition period.
QMSR becomes mandatory
In February 2024, the FDA published a "Final Rule" that amended the cGMP requirements in 21 CFR Part 820. After a transition period of two years, this means that on February 2, 2026, the FDA's QSR (Quality System Regulation) will disappear and its content will be replaced by the new 21 CFR* part 820, known as QMSR (Quality Management System Regulation).
*Code of Federal Regulations, Title 21.
The new QMSR regulation is the result of aligning the requirements of QSR with ISO 13485:2016, the international consensus standard for quality management systems for medical devices. ISO 13485:2016 is incorporated by reference, which means that ISO 13485 has the same legal effect as if its text were published in 21 CFR 820. It has the same force and effect as the law.
ISO 13485 has been revised repeatedly over the past two decades, while QSR has remained virtually unchanged since its release in 1996. These changes are intended to simplify compliance and reduce the burden on manufacturers by aligning US regulatory requirements with international standards.
The purpose of QMSR is to:
- Ensure the ability to consistently manufacture medical devices that meet applicable requirements and specifications
- Create structures to achieve quality
- Ensure that medical devices function effectively and safely
- Ensure that medical devices comply with the FDA's FD&C Act (Food Drug & Cosmetic Act)
The FDA harmonizes its QSR, 21 CFR 820, with ISO 13485 for several reasons:
- Global recognition: ISO 13485 is the internationally established standard for quality management systems for medical devices. By harmonizing with it, US manufacturers can more easily meet both US and international requirements, facilitating export and global market access.
- Reduced duplication: Today, many companies need to comply with both QSR and ISO 13485, which means duplicate systems and audits. Harmonization means that the same quality management system can comply with both regulations.
- Regulatory efficiency: The FDA wants to modernize and simplify its regulatory framework. ISO 13485 is more up to date and reflects current industry practices. By relying on it, the FDA can reduce the need for its own detailed requirements while still maintaining regulatory control.
- International convergence: This is part of a larger trend: Authorities around the world (e.g., the EU, Canada, Australia, Japan) are attempting to harmonize requirements for medical device quality management systems. This means that the FDA is no longer an "exception" but is following the same line.
- Focus on patient safety: ISO 13485 has a clearer focus on risk management and product safety throughout the entire life cycle. Harmonization helps the FDA ensure that medical devices maintain a high and consistent level of safety.
What does the transition to QMSR mean for manufacturers?
According to The Final Rule and Regulation 820.3, certain terminology and definitions are changed as they are adopted from ISO 9000:2015. For example, the current DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record) are replaced by Design and Development File, Medical Device File, and Medical Device Batch Record from ISO 13485. However, for certain terms, the FDA's definitions, as described in The Final Rule and Regulation §820.3, still apply. Some examples where the FDA's definitions exceed ISO 13485 are:
- Component: The FDA has a broader definition and refers to all raw materials, substances, parts, software, firmware, labeling, or subassemblies that are intended to be included as part of the finished, packaged, and labeled device.
- Finished device: The FDA includes accessories in the definition and thus refers to any product or accessory to a product that is suitable for use or can function, regardless of whether it is packaged, labeled, or sterilized.
- Remanufacturer: The FDA defines a remanufacturer as a person who processes, refurbishes, repackages, restores, or otherwise takes any action with a finished product that significantly alters the finished product's performance, safety specifications, or intended use. If this occurs, the same regulatory requirements apply as for original manufacturers.
- Manufacturer: The FDA includes more roles and functions, such as relabeling and initial distribution. Those who perform contract sterilization, installation, repackaging, or specification development are also included.
- Safety and Performance: The FDA considers this concept to be equivalent to "safety and effectiveness" in ISO 13485. The term "Safety and Performance" does not exempt a manufacturer from the obligation to implement controls or other measures that provide reasonable safety and effectiveness.
As a manufacturer, you should adapt your processes and documents to include these amended FDA definitions.
Additional differences between QSR and QMSR according to the FDA's Final Rule
Regulation 820.10 Requirements for Quality Management Systems. The FDA incorporates ISO 13485 while retaining other FDA regulations such as 21 CFR parts 830, 821, 803, and 806.
Regulation 820.35 Control of Records. The FDA defines content requirements for complaint and service records and when customer complaints must be investigated. The FDA also clarifies how organizations should handle multiple entities that handle customer complaints. They urge companies to "define their customer complaint handling process at the corporate level to ensure a consistent process for the entities that handle customer complaints."
Regulation 820.45 Device Labeling and Packaging Controls. The FDA considers the handling of control and inspection of labeling and packaging in ISO 13485 to be insufficient. QMSR requires manufacturers to inspect product labels for certain elements before release, in accordance with the requirements of current 21 CFR 820.120 (b)e.
Transition to QMSR – what do manufacturers need to consider?
An ISO 13485-certified company that is already QSR-compliant needs to make a minor effort, such as a GAP analysis where measures are prioritized to demonstrate the company's compliance status with QMSR. If the FDA comes knocking on February 2, 2026, or later, at least one gap analysis will be needed to show that the quality management system has been reviewed with regard to QMSR.
What is at stake?
Failure to comply with QMSR means that the product may be reclassified as "adulterated" or improper, and the FDA may take regulatory action such as ordering a recall, prohibiting sales, or imposing an import ban.
Time is a challenge. The transition period is coming to an end, and many organizations are still in the interpretation phase rather than the implementation phase. This is where the risks increase, especially for companies with no previous experience of FDA inspections.
Three questions to ask within the organization:
1. Do we have clear traceability between ISO 13485, our internal QMS structure, and the FDA's definitions according to §820.3?
2. Have we conducted or planned a GAP analysis against QMSR, and what does our action strategy look like?
3. How do we document regulatory readiness if an FDA inspection were to take place from February 2026 onwards?
Continue the dialogue
It is easy to view QMSR as just another in a series of regulatory changes, but in reality, it is not an option. For manufacturers, it is a necessary step to ensure continued market access, strengthen their quality system, and meet the requirements for future FDA inspections. Adapting is not just a strategic advantage; it is a business-critical necessity.
Does this seem problematic? We are here to support you and are happy to continue the dialogue where it is most needed if you require support or advice. We are happy to share our perspectives and help you move forward. Please contact us in the way that suits you best.
