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 throughout the lifecycle of the cyber device, and for other purposes.
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.
Received in the Senate.
Referred to the Subcommittee on Health.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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