Senate bill S3983-117

Health, Education, Labor, and Pensions Committee

A bill to amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness thro

• Last activity on Mar 31, 2022

• Introduced Mar 31, 2022

• By Sen. Cassidy, Bill [R-LA]

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Main Subject: Health

PATCH Act

This bill requires premarket applications for cyber devices (i.e., medical devices that include software or connect to the internet) to include information relating to cybersecurity, including plans to monitor for cybersecurity risks and address vulnerabilities through regular product updates.

HR7084-117, HR7667-117,

Senate Actions

IntroReferral
Mar. 31 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Library of Congress Actions

IntroReferral
Mar. 31 2022	Introduced in Senate

Senate bill S3983-117

A bill to amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness thro

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