FDA finalizes rule to scale back how it regulates medtech software

The FDA today issued a ruling that amends medical device classification regulations related to the 21st Century Cures Act.

In an unpublished ruling (it will officially be published on Monday, April 19, 2021), the FDA stated that it took this action to ensure that its regulations conform to the medical software provisions in the Cures Act.

In December 2016, then-President Barack Obama signed the 21st Century Cures Act, which included some provisions intended to improve the regulatory process for medical devices.

Among the provisions was a clarification on the FDA’s role in regulating medical software. Previously, the FDA had regulated image analysis software and IVD technology — and continued to do so after Obama signed the 21st Century Cures Act. However, under the law’s provision, the FDA can not regulate software that uses “big data” to provide clinical decision support to healthcare professionals.

The section has a few exceptions fo…

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