summary
Introduced
03/31/2022
03/31/2022
In Committee
03/31/2022
03/31/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to require, for purposes of ensuring cybersecurity, the inclu- sion 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.
AI Summary
This bill, the PATCH Act, amends the Federal Food, Drug, and Cosmetic Act to require the inclusion of cybersecurity information in any premarket submission for a "cyber device" (a device that includes software or is intended to connect to the internet). This information must demonstrate a reasonable assurance of safety and effectiveness throughout the device's lifecycle, including requirements for the manufacturer to monitor and address cybersecurity vulnerabilities, have a Coordinated Vulnerability Disclosure plan, and provide updates and patches to address known vulnerabilities. The bill also allows the Secretary to find a device not substantially equivalent based on inadequate cybersecurity information and makes the failure to comply with the cybersecurity requirements a prohibited act and a reason for a device to be considered adulterated or misbranded.
Committee Categories
Health and Social Services
Sponsors (2)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 03/31/2022)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/senate-bill/3983/all-info |
| BillText | https://www.congress.gov/117/bills/s3983/BILLS-117s3983is.pdf |
| Bill | https://www.congress.gov/117/bills/s3983/BILLS-117s3983is.pdf.pdf |
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