[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3005 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 3005

   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.


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Testing Availability Act of 
2013''.

SEC. 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.''.
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