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Medical Device Safety Alerts: New Rules for Public Warnings

This bill changes how the government warns the public about potential safety issues with medical devices. It sets clear steps for issuing alerts based on new information, ensuring patients and doctors get timely updates about potential risks and benefits.
Key points
Government must warn the public quickly about new potential risks from medical devices if needed.
Warnings must include all known information, including benefits and risks, and consider manufacturer input.
Warnings will be updated regularly and reviewed to see if they are still necessary.
Government must use credible scientific evidence for warnings and share underlying data from third-party studies with manufacturers.
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Status:
Expired
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Additional Information
Print number: 117_S_4349
Sponsor: Sen. Marshall, Roger [R-KS]
Process start date: 2022-06-06
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-04-17
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4349.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-06-06.

What are the main provisions?

Key points include:

  • Government must warn the public quickly about new potential risks from medical devices if needed.
  • Warnings must include all known information, including benefits and risks, and consider manufacturer input.
  • Warnings will be updated regularly and reviewed to see if they are still necessary.
  • Government must use credible scientific evidence for warnings and share underlying data from third-party studies with manufacturers.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Marshall, Roger [R-KS].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-29.

What is the impact of this bill?

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge.

CATEGORIES

Health