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HR 3211 112th Congress House

Humanitarian Device Reform Act of 2011

Official title: To amend the Federal Food, Drug, and Cosmetic Act to improve humanitarian device regulation.

Introduced: October 14, 2011 See on congress.gov
Health Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Health technology, devices, supplies
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) 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
Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
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 Latest action October 18, 2011

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 9
All 9 Republican 3
Meehan, Patrick
· Jan 24, 2012
CULBERSON, JOHN
· Oct 27, 2011
 R
Blackburn, Marsha
Tennessee · Oct 14, 2011
 R
Guthrie, Brett
Kentucky · Oct 14, 2011
Lance, Leonard
· Oct 14, 2011
 R
Latta, Robert E.
Ohio · Oct 14, 2011
Paulsen, Erik
· Oct 14, 2011
Rogers, Mike
· Oct 14, 2011
SHIMKUS, JOHN
· Oct 14, 2011
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3211: Humanitarian Device Reform Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3211/
MLA
"H.R. 3211: Humanitarian Device Reform Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3211/.
Bluebook (legal)
H.R. 3211, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3211/.
Markdown link
[H.R. 3211: Humanitarian Device Reform Act of 2011](https://openamerica.io/bill/112-HR-3211/)
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