To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.

Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2428 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2428

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
              humanitarian device exemption applications.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

 Mr. Shimkus introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
              humanitarian device exemption applications.

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

SECTION 1. HUMANITARIAN DEVICE EXEMPTION APPLICATION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended--
            (1) in paragraph (1) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000'';
            (2) in paragraph (2)(A) by striking ``fewer than 4,000'' 
        and inserting ``not more than 8,000''; and
            (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
        inserting ``8,000''.
    (b) Guidance Document on Probable Benefit.--Not later than 18 
months after the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall publish a draft guidance document that defines the criteria for 
establishing ``probable benefit'' as that term is used in section 
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(2)(C)).
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