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HR 3203 112th Congress House

Novel Device Regulatory Relief Act of 2011

Official title: To amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device.

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

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 15
All 15 Republican 5
R
Gosar, Paul A.
Arizona · Apr 24, 2012
MATHESON, JIM
· Feb 1, 2012
Rokita, Todd
· Jan 23, 2012
 R
Calvert, Ken
California · Nov 1, 2011
WALDEN, GREG
· Nov 1, 2011
CULBERSON, JOHN
· Oct 24, 2011
 R
Blackburn, Marsha
Tennessee · Oct 14, 2011
Dent, Charles
· Oct 14, 2011
 R
Guthrie, Brett
Kentucky · Oct 14, 2011
Hunter, Duncan
· Oct 14, 2011
Lance, Leonard
· Oct 14, 2011
 R
Latta, Robert E.
Ohio · Oct 14, 2011
Paulsen, Erik
· Oct 14, 2011
SHIMKUS, JOHN
· Oct 14, 2011
STEARNS, CLIFF
· Oct 14, 2011
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3203: Novel Device Regulatory Relief Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3203/
MLA
"H.R. 3203: Novel Device Regulatory Relief Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3203/.
Bluebook (legal)
H.R. 3203, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3203/.
Markdown link
[H.R. 3203: Novel Device Regulatory Relief Act of 2011](https://openamerica.io/bill/112-HR-3203/)
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