Heads Up!

The Food and Drug Administration (FDA) will soon change the regulatory requirements for medical device manufacturers and their suppliers. We want to be sure affected manufacturers know about the new framework.

The change, which takes effect on February 2, 2026, closely aligns FDA requirements with the International Standard Organization’s (ISO) medical device framework, known as ISO 13485:2016. When the rule becomes effective, the United States will join several other major countries and trading blocs, including Canada, the European Union, and Japan, in relying on ISO 13485 as the core basis for their current good manufacturing practice requirements for medical devices.

That’s a shift from the past several decades, when many medical device manufacturers and their suppliers operated under both FDA rules and ISO guidelines. In 1996, the FDA significantly revised the medical device regulatory climate when it established the quality system regulation.

Also in 1996, ISO issued the first version of ISO 13485, ‘‘Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001.” Over time, ISO 13485 has evolved into a stand-alone standard that outlines quality management system (QMS) requirements for medical devices.

With each revision, ISO 13485 has aligned more closely with the requirements set by the FDA. This progression enabled the FDA to harmonize its regulations by incorporating the QMS requirements of ISO 13485.

The FDA estimates this regulatory alignment will save the medical device industry something like $500 million a year. Officials also expect the change will result in quicker access to newly developed medical devices.

Stay tuned for information on how Enterprise Minnesota’s team of ISO experts can help your company adjust to these regulatory changes.

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