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HR 2915 116th Congress House

Medical Device Guardians Act

Official title: 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 cer… Show full official titleShow less

Official title: 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.

Introduced: May 22, 2019 Introduced by: Fitzpatrick, Brian K. Republican · Pennsylvania See on congress.gov
Health Drug safety, medical device, and laboratory regulationGovernment information and archivesHealth care qualityHealth information and medical records
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Health personnelHealth technology, devices, suppliesProduct safety and quality
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 23, 2019
Referred to the Subcommittee on Health.
May 22, 2019
Referred to the House Committee on Energy and Commerce.
May 22, 2019
Introduced in House
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 Latest action May 23, 2019

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 3
D
DeLauro, Rosa L.
Connecticut · May 22, 2019
 D
Doggett, Lloyd
Texas · May 22, 2019
 D
Schakowsky, Janice D.
Illinois · May 22, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2915: Medical Device Guardians Act. 116th Congress. Open America. https://openamerica.io/bill/116-HR-2915/
MLA
"H.R. 2915: Medical Device Guardians Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-2915/.
Bluebook (legal)
H.R. 2915, 116th Cong. (2026), https://openamerica.io/bill/116-HR-2915/.
Markdown link
[H.R. 2915: Medical Device Guardians Act](https://openamerica.io/bill/116-HR-2915/)
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