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The rule, which has now been in effect for a few weeks as of the publication of this article, introduced additional requirements and clarifications of expectations in ISO 13485:2016 and clarified that any clauses that conflict with provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act would be superseded by the FD&C Act.
In preparation for the FDA's Quality Management Systems Regulation (QMSR) coming into effect in February 2026, many professionals in the medical device industry are seeking clarification on what the new requirements mean in practice.
To help you with this transition, here is a list of frequently asked questions based on official FDA guidance. For readers who would like to review the original, complete source, the FDA reference is included at the end of this article.
What happens if ISO 13485:2016 is revised?
Any future revisions to this standard would need to be evaluated to determine the impact of the changes and whether the QMSR should be amended. If needed, amendments to the QMSR will be implemented through rulemaking. However, ISO 13485:2016 was reviewed and confirmed as is in 2025, and any possible changes to the standard won’t come up until it is up for review again in 2030.
What is the FDA doing to prepare for implementation of the QMSR?
The Agency will be engaging in a variety of implementation activities, including updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection process, revising relevant regulations and other documents impacted by this rulemaking, and communicating with and educating stakeholders, including affected FDA staff, on the change.
What records does the FDA intend to review during inspections conducted on or after February 2, 2026?
To help determine compliance with the QMSR, FDA investigators may review records that are part of the manufacturer’s QMS, including those created before February 2, 2026. As set forth in the preamble to the final rule, the requirements of the QSR and the QMSR are substantially similar. A manufacturer may find it useful to complete some type of comparative analysis to demonstrate that documents and records created prior to the QMSR effective date meet the QMSR requirements.
Will there be a new inspection process, and where do I find information about the new inspection process for QMSR?
Yes, the FDA will have a new inspection process to align with the requirements of the Quality Management System Regulation (QMSR). On February 2, 2026, the Quality System Inspection Technique (QSIT) will be withdrawn, and the new inspection process will be implemented.
The QMSR inspection process will be documented in a revised version of the Compliance Program (CP), Inspection of Medical Device Manufacturers. The revised CP will be effective on February 2, 2026, and will be available on the FDA device CP webpage no later than the QMSR effective date. The device CPs are available here: Center for Devices and Radiological Health (CDRH) Compliance Programs | FDA.
How will FDA device inspections under the QMSR compare to Medical Device Single Audit Program (MDSAP) audits?
FDA inspections under the QMSR will not follow the MDSAP audit plan or procedures. The FDA will not require certificates of conformance to ISO 13485 and will not issue certificates of conformance to ISO 13485. A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection. FDA inspections assess compliance with FDA regulations and are scheduled based on risk factors. Third-party audits assess conformance to a standard and occur annually based on a three-year plan.
MDSAP is a voluntary third-party audit program and will still be available to manufacturers who choose to participate.
Still Have More Questions?
The answers to the five common questions regarding the FDA’s QMSR final rule offer insights into how the new requirements are being enforced from February 2 moving forward. Medical device manufacturers that supply the U.S. market must now ensure that their quality management systems are in line with applicable QMSR requirements while continuing to comply with FDA-specific regulatory obligations.
If you are still navigating the regulatory implications of the QMSR, you may find it helpful to first read our article “FDA’s Quality Management System Regulation (QMSR) Final Rule”, which provides a comprehensive overview of the final rule and its regulatory intent, before exploring the practical implementation aspects discussed here.
Explore the Topic Further in Our Live Session
At PQE Group, we understand the challenges that come with regulatory changes and updates, and in accordance with our mission to support medical device manufacturers in the U.S. market, as we continue to support the life sciences industry, we are hosting a free live webinar on February 19, 2026.
Join us and our experts for the ‘QMSR Transition Explained: Mastering the Shift in 21 CFR Part 820’ webinar as we break down the differences between the legacy Quality System Regulation (QSR) and the new and current Quality Management System Regulation (QMSR), and more.
If you want to gain a deeper understanding of how QMSR aligns with ISO 13485:2016 and how this harmonization will impact operating in the U.S., EU, and other global markets, this live discussion is for you.
Source: FDA, Quality Management System Regulation – Frequently Asked Questions,
