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Enhanced Transparency for Medical Device Risks

This act aims to improve patient safety by providing faster public notification of potential risks associated with medical devices. Citizens will have access to more current and comprehensive risk information, enabling them to make informed treatment decisions. Device manufacturers will have an opportunity to provide input before warnings are published.
Key points
Faster public notification of new, potential risks related to medical devices.
Risk information will be based on credible scientific evidence and include known benefits of the device.
Device manufacturers will have the right to comment on information before public release.
Notifications will be regularly updated, and unconfirmed risks will be rescinded.
Increased transparency regarding third-party data used for medical device decisions.
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Additional Information
Print number: 117_HR_7646
Sponsor: Rep. Guthrie, Brett [R-KY-2]
Process start date: 2022-05-03