To amend the Federal Food, Drug, and Cosmetic Act to require physicians and physician's offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.
Medical Device Guardians Act
This bill requires physicians to report significant adverse experiences caused by medical devices to the Food and Drug Administration (FDA).
The FDA must establish an electronic reporting system to facilitate compliance with this bill and must publish the reports online.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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