Legislation Detail — AIHealthcare

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21st Century Cures Act — Clarifying Medical Software Regulation

United States (Federal) | H.R. 34 (Pub. L. 114-255), Section 3060

Year Enacted

2016

Date Signed

Dec 13, 2016

Effective Date

Dec 13, 2016

Status

Enacted

Enacted; amended the FD&C Act definition of 'device' to exclude certain clinical decision support software

Key Requirements

Amended the FD&C Act to exclude five categories of software from the medical device definition. For clinical decision support (CDS) software, exclusion applies if the software enables healthcare professionals to independently review the basis for recommendations and is not intended as the primary basis for clinical decisions. High-risk autonomous AI remains regulated as a device.

Regulated Parties

Medical device manufacturers; health IT developers; clinical decision support software developers

Enforcement

FDA (Center for Devices and Radiological Health)

Sources

Official https://www.congress.gov/bill/114th-congress/house-bill/34

Secondary https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

Notes

Foundational law for AI in healthcare. Codified at Section 520(o)(1)(E) of the FD&C Act. Does NOT exclude high-risk autonomous AI from FDA oversight.

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