FDA Regulation of AI-Enabled Devices

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FDA Regulation of AI-Enabled Devices

Published Jun 10, 2026Updated Jun 11, 2026

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The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.

HR 34114th Congress
21st Century Cures Act
Dec 13, 2016 · Became Public Law No: 114-255.
HR 2617117th Congress
Consolidated Appropriations Act, 2023
Dec 29, 2022 · Became Public Law No: 117-328.

FDA Regulation of AI-Enabled Devices

Legislation this report covers