Finally, the US Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR) final rule that harmonizes the requirements with a well-recognized International Organization for Standardization (ISO) standard.

As per the FDA, it is going to bring lagging consistency in the regulatory expectations for the medical device manufacturers which will save them millions of dollars annually.

On January 31st, FDA published this new QMSR final rule that has been long-awaited. According to this, the rile has amended the current FDA’s medical device good manufacturing practice (CGMP) expectations under the quality system (QS) regulation, aligning with ISO 13485:2016.

“This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH).

The intent of FDA behind harmonizing this area of medical device manufacturer’s quality management system with international standards is to streamline the actions of device manufacturers to meet requirements by multiple regulatory authorities.

Key Note: All the manufacturers are required to come into compliance with the new rule by Feburary 2nd, 2026 and can continue to comply with current QS regulation until then.

The good thing is that the requirements in ISO 13485 are quite similar to those of QS regulations. This means that it offers same assurance that medical device manufacturer’s quality management system is compliant with all the required regulatory expectations.

In fact, FDA mentioned that while the new rule retains the scope of the QS regulation, its provisions are amended.

“We are also amending the title of the regulation and establishing additional requirements and provisions that clarify certain expectations and certain concepts used in ISO 13485,” the agency added.

At Elexes regulatory consulting, we can help manufacturers streamline the transition to the new QMSR rule. All you need to do is contact us and we will guide you through all steps.