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FDA’s Quality System Final Rule a Significant Revision

The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the previous version in several key respects, although little information is available regarding how the FDA will alter its approach to inspections under the QMSR.

The QMSR replaces the Quality System Regulation (QSR) and incorporates several sections of ISO 13485 by reference rather than by simply replicating the related elements of ISO 13485. As is the case with the QSR, the QMSR applies to all high-risk (class III) devices, all medium-risk (class II) devices and a small subset of class I devices. The final QMSR rule goes into effect Feb. 2, 2026, prior to which inspections will be conducted under the QSR. The FDA’s existing inspectional framework for medical device manufacturing establishments will no longer be used after that date, but the agency has provided no information about how it intends to amend its approach to inspections under the QMSR.

This is an especially important consideration as the QMSR allows FDA investigators to examine a larger range of documentsRegulation Compliance during routine inspections than was allowed under the QSR. In the past, and up until February 2026, FDA staff were not authorized to require access to documents related to management reviews of the manufacturer’s quality system. This was true also of quality audit reports. Under the QMSR, however, the FDA field investigator will be authorized to review those records during routine surveillance inspections, a significant shift in FDA policy, and one which harmonizes with ISO 13485.

As part of the changes in terminology and definitions, the QMSR will not refer to “safety and effectiveness” as a regulatory term, but instead will use the term “safety and performance” to align with ISO 13485. Another change undertaken to align with ISO 13485 is the change from the title of the design history file to the design and development file. Additionally, device master record files will be renamed medical device files, although the content required will be essentially the same.

Several elements of the QSR carried over into the QMSR, such as that manufacturers of components will not be routinely subject to the regulation. The FDA stated, however, that it has the legal authority to impose the related regulatory requirements on these manufacturers. Third parties that service and/or refurbish medical devices are also not typically subject to the regulation. However, the device component of a combination device will be subject to the requirements of the QMSR.

The FDA provided two estimates of the cost of implementation for manufacturers, including an annualized net cost savings of approximately $532 million. This figure assumes a 7% percent discount rate, while an assumed discount rate of 3% would result in annualized cost savings of $561 million. The agency said other cost savings will accrue because of the alignment of the QMSR with other related programs.

There are several potential difficulties associated with the alignment with ISO 13485, principally those associated with any future changes to the ISO standard. Because ISO 13485 is copyrighted, the FDA cannot align with any future changes by copying those changes verbatim. This consideration drove the FDA to incorporate the related elements of 13485 by reference rather than by simply duplicating the language in the ISO standard.

Should the ISO standard be updated, the FDA will have to undergo a new notice-and-comment process as is legally required for rulemaking by U.S. government agencies. This could require a substantial period of time, as suggested by the time needed to complete this first version of the QMSR, which came out in draft form in February 2022. The final rule will go into effect a total of four years after the date of the draft, which suggests that rulemaking for any future conforming revisions of the QMSR may require substantially longer than a year to complete.

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