I 
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 equiva-
lence determinations for devices, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Product Re-
view Harmonization Act of 2017’’. 
SEC. 2. ALTERNATIVE SUBSTANTIAL EQUIVALENCE SHOW-
ING. 
Subsection 513(i)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(i)(1)) is amended— 
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(1) 
by 
redesignating 
subparagraphs 
(B) 
through (F) as subparagraphs (C) through (G), re-
spectively; 
(2) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B)(i) As an alternative to clause (ii) of subpara-
graph (A), and for the purpose of determining substantial 
equivalence under subsection (f) and section 520(l), a per-
son may submit information to the Secretary that dem-
onstrates that a device conforms with national or inter-
national 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 stand-
ard, 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 equiva-
lence under this paragraph; and 
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‘‘(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), com-
ply 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 ap-
plicable, 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 docu-
ments to demonstrate substantial equivalence as described 
in subparagraph (B) shall be optional and have no effect 
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