[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2474 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2474

    To amend the Federal Food, Drug, and Cosmetic Act to provide an 
  alternative standard for substantial equivalence determinations for 
                    devices, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 16, 2017

 Mrs. Mimi Walters of California (for herself and Mr. Bera) 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 to provide an 
  alternative standard for substantial equivalence determinations for 
                    devices, and for other purposes.

    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 Product Review Harmonization 
Act of 2017''.

SEC. 2. ALTERNATIVE SUBSTANTIAL EQUIVALENCE SHOWING.

    Subsection 513(i)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(i)(1)) is amended--
            (1) by redesignating subparagraphs (B) through (F) as 
        subparagraphs (C) through (G), respectively;
            (2) by inserting after subparagraph (A) the following:
    ``(B)(i) As an alternative to clause (ii) of subparagraph (A), and 
for the purpose of determining substantial equivalence under subsection 
(f) and section 520(l), a person may submit information to the 
Secretary that demonstrates that a device conforms with national or 
international standards, standards established or recognized under 
section 514, or guidance documents developed by the Secretary to 
demonstrate that a device is as safe and effective as a legally 
marketed device, notwithstanding technological differences.
    ``(ii) Any person may propose to the Secretary, for purposes of 
clause (i), a national or international standard, a standard 
established or recognized under section 514, or a guidance document 
developed by the Secretary. Not later than 60 days after receipt of any 
such proposal, the Secretary shall provide to the person submitting the 
proposal a written determination--
            ``(I) accepting all, part, or none of the proposal for 
        purposes of demonstrating substantial equivalence under this 
        paragraph; and
            ``(II) stating the full rationale (including the 
        scientific, technical, and regulatory basis) for the 
        Secretary's determination.
    ``(iii) The Secretary shall--
            ``(I) except as provided in subclause (II), comply with the 
        requirements for public participation described in section 
        701(h)(1)(C) before first using a standard or guidance document 
        for purposes of this subparagraph; and
            ``(II) in the case of establishing or recognizing a 
        standard, comply with the requirements described in section 514 
        for establishing or recognizing, as applicable, a performance 
        standard.
    ``(iv) A person submitting a notification under section 510(k) may 
rely on a standard or guidance document identified, established, or 
recognized by the Secretary in accordance with clause (iii) to resolve 
some or all of the differences that exist between a new device and its 
legally marketed predicate device to demonstrate substantial 
equivalence.''; and
            (3) in subparagraph (F) (as redesignated by paragraph (1)), 
        by adding at the end the following:
    ``(iv) The reliance on standards or guidance documents to 
demonstrate substantial equivalence as described in subparagraph (B) 
shall be optional and have no effect on the establishment of 
substantial equivalence pursuant to subparagraph (A) where such option 
is not exercised.''.
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