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HR 3005 113th Congress House

Medical Testing Availability Act of 2013

Official title: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit the sale of, and access to, "research use only" products in diagnostic tests.

Introduced: October 7, 2013 See on congress.gov
Health Consumer affairsDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesMedical researchProduct safety and quality
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This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) 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
Aug 2, 2013
Referred to the Subcommittee on Health.
Aug 2, 2013
Referred to the House Committee on Energy and Commerce.
Aug 2, 2013
Introduced in House
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 Latest action August 2, 2013

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval.

Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner inconsistent with such statement, or (2) engages in business communications regarding the product with an end user.

Defines "business communications": (1) as oral, written, or electronic contact between a manufacturer or distributor of such a product and an end user regarding the product's functioning; and (2) includes any such contact consisting of technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 4
All 4 Democratic 2
D
Peters, Scott H.
California · Nov 18, 2013
 D
Brownley, Julia
California · Oct 7, 2013
Granger, Kay
· Sep 26, 2013
HONDA, MICHAEL
· Sep 10, 2013
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3005: Medical Testing Availability Act of 2013. 113th Congress. Open America. https://openamerica.io/bill/113-HR-3005/
MLA
"H.R. 3005: Medical Testing Availability Act of 2013." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-3005/.
Bluebook (legal)
H.R. 3005, 113th Cong. (2026), https://openamerica.io/bill/113-HR-3005/.
Markdown link
[H.R. 3005: Medical Testing Availability Act of 2013](https://openamerica.io/bill/113-HR-3005/)
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