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HR 5404 114th Congress House

Medical Device Guardians Act of 2016

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: June 22, 2016 See on congress.gov
Health Drug safety, medical device, and laboratory regulationHealth care qualityHealth information and medical recordsHealth personnel
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Health technology, devices, suppliesProduct safety and quality
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) 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 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 8, 2016
Referred to the House Committee on Energy and Commerce.
Jun 8, 2016
Introduced in House
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 Latest action June 8, 2016

Referred to the House Committee on Energy and Commerce.

 Plain-English summary Congressional Research Service

Medical Device Guardians Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring physicians to report to the Food and Drug Administration about significant adverse experiences caused by medical devices.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 4
All 4 Democratic 1 Republican 2
R
Smith, Christopher H.
New Jersey · Jul 14, 2016
 D
Lynch, Stephen F.
Massachusetts · Jun 22, 2016
LOBIONDO, FRANK
· Jun 14, 2016
 R
Zinke, Ryan K.
Montana · Jun 8, 2016
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5404: Medical Device Guardians Act of 2016. 114th Congress. Open America. https://openamerica.io/bill/114-HR-5404/
MLA
"H.R. 5404: Medical Device Guardians Act of 2016." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-5404/.
Bluebook (legal)
H.R. 5404, 114th Cong. (2026), https://openamerica.io/bill/114-HR-5404/.
Markdown link
[H.R. 5404: Medical Device Guardians Act of 2016](https://openamerica.io/bill/114-HR-5404/)
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