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HR 3005 113th Congress House Health Consumer affairs Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Medical research Product safety and quality

Medical Testing Availability Act of 2013

Introduced: August 2, 2013 See on congress.gov
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 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
 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.

What's happening now August 2, 2013

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Democratic 2