Medical Testing Availability Act of 2013

Bill: 113-hr-3005
Sponsor: full_name: Rep. Burgess, Michael C. [R-TX-26]
Introduced: 2013-08-02
Policy area: Health
Subjects: Consumer affairs

Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies

Medical research

Product safety and quality
Latest action: action_date: 2013-08-02
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2013-08-02
action_desc: Introduced in House
text: <p>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.</p> <p>Declares that such a product whose labeling states <i>"For Research Use Only. Not for use in diagnostic procedures."</i> 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.</p> <p>Defines &quot;business communications&quot;: (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.</p>

tv_txt: I 113th CONGRESS 1st Session H. R. 3005 IN THE HOUSE OF REPRESENTATIVES August 2, 2013 Mr. Burgess (for himself and Ms. Speier ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.

1. Short title This Act may be cited as the Medical Testing Availability Act of 2013 . 2. Clarification regarding research use only products Section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j ) is amended by adding at the end the following subsection: (o) Products with research use only labeling (1) In general A product whose labeling bears the statement described in section 809.10(c)(2)(i) of title 21, Code of Federal Regulations, as in effect on the date of the enactment of this subsection, may not be deemed to be misbranded under this Act on the basis that the manufacturer or distributor of the product— (A) sells the product to an end user who uses the product in a manner inconsistent with such statement; or (B) engages in business communications regarding the product with an end user of the product. (2) Business communications defined In this subsection, the term business communications , with respect to a product with labeling described in paragraph (1)— (A) means oral, written, or electronic contact between a manufacturer or distributor of such product and an end user regarding the functioning of such product; and (B) 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. (3) Sunset This subsection shall cease to be effective on the last day of the five-year period beginning on the date of enactment of this section. .