As the thrill from the 2026 New Year’s ball drop starts to quiet down, it is time to await the countdown of yet another exciting event this year. Ladies and gentlemen, it’s transition time. 

Feb. 2, 2026, marked the start for the implementation of the new U.S. Quality Management System Regulation (QMSR). The previous Quality System Regulation (QSR) requirements have had no significant changes since their release in 1996. Now, it’s time to shake things up. 

The intention behind this final rule is to create more globally harmonized quality management system requirements by incorporating global standards ISO 13485:2016 and Clause 3 of ISO 9000. The new QMSR provides a structural alignment and harmonization change without lowering expectations for current good manufacturing practices (CGMP) from the previous regulation. It is important to note that although ISO 13485 is incorporated into the new regulation by reference, compliance to ISO 13485:2016 alone is not sufficient as the new regulation includes U.S.-specific supplemental provisions, in addition to ISO 13485 requirements. ISO 13485 uses a risk-based approach through the entire product lifecycle, which companies will now be expected to incorporate into their management system. 

The good news is that companies already compliant to ISO 13485 have a head start. The bad news, conforming to ISO 13485 alone is not enough to comply with the new QMSR.

ISO 13485’s role in the new regulation is to provide a globally harmonized standard with the intent of streamlining compliance for manufacturers who have a global presence in the device market. The U.S. Food and Drug Administration (FDA) believes the requirements of ISO 13485 can ensure safe and effective devices, similar to the previous regulation. While the legacy QSR confined risk management to design controls, ISO 13485 includes a strong focus on a risk-based approach throughout the device lifecycle. Overall, the inclusion of ISO 13485 mirrors an modernized view on quality systems for device manufacturers.

Manufacturers of medical devices are required to have a controlled quality management system to support consistency and reliability of their products. The U.S. quality requirements, laid out in 21 Code of Federal Regulations (CFR) Part 820, provides a framework for maintaining a good quality system for medical device manufacturers. Specifics on how a manufacturer conducts their quality system remains the responsibility of the manufacturer and should be based on the complexity and risk of their devices, along with the structure of their establishment. When the FDA released the QMSR Final Rule on Feb. 2, 2024, it included a two-year transition period. As manufacturers head into the start of 2026, it’s time to ensure their quality system is aligned with the new QMSR.

Of the 30 total pages of the QMSR Final Rule document, only the last three pages contain the regulation itself. The first 27 pages include summary and background information along with the public comments and the FDA’s responses submitted during the draft period. Those interested in the more detailed reasoning behind the recent changes should consider reading through the public comments in the regulation document. For everyone else, let’s look at the Cliff Notes.

Let’s first break down what is required for manufacturers to be compliant with the new 2026 QMSR, starting with what has not changed. The scope of the previous 1996 QSR remains unchanged. One of the intentions for the incorporation of ISO 13485 is the substantially equivalent scope and intent. The FDA retains inspection authority and will inspect to the new QMSR requirements. Although the new QMSR incorporates ISO 13485:2016, FDA will not issue certificates for this standard after the completion of inspections. 

Additionally, having an ISO 13485 certificate will not exempt a manufacturer from the requirements of audit inspections. The FDA is currently in the process of updating their own internal procedures, policies, and inspection documents to align with the new expectations. FDA inspectors must also be educated on the new inspection requirements. Current plans included withdrawing the Quality System Inspection Technique (QSIT) on Feb. 2, 2026, to replace it with an updated inspection process. 

Now to the critical part—what’s different in the new regulation. 

Subpart A of the new QMSR includes the general provisions of the regulation. Here FDA provides the scope, definitions, and requirements for a quality system, most of which points to the ISO 13485:2016 requirements, with a few exceptions. The regulation explicitly states that in any situation where the QMSR, or ISO 13485, conflicts with the Federal Food, Drug, and Cosmetic Act, the Federal FD&C Act regulations supersede all others. Definitions are included in 21 CFR Part 820.3, where it now states that, other than a handful of definitions included in paragraphs (a) and (b), the definitions from ISO 13485:2016 and Clause 3 of ISO 9000 apply. In 21 CFR 820.3 part (a), FDA defines several terms which are not used or not defined in the ISO standards including: component, Federal Food, Drug, and Cosmetic Act, finished device, human cell/tissue/cellular or tissue-based product (HCT/P), and remanufacturer. FDA also defines a few additional terms in part (b) which supersede the definitions in the ISO standards including implant, manufacturer, organization, and rework. The QMSR also refers to “performance and safety” instead of “safety and effectiveness” referenced in ISO 13485.

Subpart B of the new QMSR includes the supplemental provisions where FDA included U.S.-specific additional requirements beyond the requirements of ISO 13485. Control of records, set out in 21 CFR Part 820.35, has transitioned to rely heavily on the requirements in ISO 13485 but includes additional requirements for items such as: records of complaints, records of servicing activities, Unique Device Identification (UDI), and confidentiality of records. Device labeling and packaging controls, set out in 21 CFR 820.45, includes additional labeling requirements for U.S. manufacturers outside of the ISO 13485 requirements including: UDI or UPC, expiration date, storage instructions, handling instructions, and any processing instructions that must be included on device labeling. Additional U.S.-specific supplemental provisions include: complaint handling, risk management documentation requirements, and clarifications on records/corrections/data analysis.

So, what are the recommended next steps for manufacturers? First step is to become familiar with both the Quality System Management Regulation and ISO 13485. The QMSR can be found on the Federal Register website (Federal Register :: Medical Devices; Quality System Regulation Amendments) while the ISO 13485:2016 standard is available in a read-only format through the American National Standards Institute (ANSI) website (ISO IBR Standards Available). 

After becoming familiar with the new requirements, manufacturers should consider conducting a gap analysis of their current quality system. A gap analysis should ensure the manufacturer’s quality system aligns with ISO 13485, includes all supplemental provisions from 21 CFR Part 820 Subpart B, incorporates risk management integration into the entire product lifecycle, includes updates to internal audit and management reviews to reflect the new regulation expectations, and appropriate training is executed for team members on the new policies and procedures. 

The QMSR Final Rule represents the most significant change to U.S. medical device quality regulation in nearly three decades. While harmonization with ISO 13485 reduces global compliance redundancy, manufacturers must recognize that compliance to ISO 13485 alone does not equate to compliance to the QMSR. 

For device manufacturers, this rule should not be viewed as a burden, but as an opportunity to modernize quality systems, improve lifecycle risk management, and streamline global market access—while maintaining the FDA’s longstanding emphasis on safety and effectiveness of medical devices. 

Let the countdown begin.

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Hannah Taggart is a forward-thinking biomedical engineer and regulatory specialist with ATS Colorado Springs who is helping to navigate clients through the complex regulatory landscape to provide innovative and compliant medical devices for their patients.