I 
114TH CONGRESS 
1ST SESSION H. R. 2426 
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing 
regulatory burden with respect to certain class I and class II devices. 
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 easing regulatory burden with respect to cer-
tain class I and class II devices. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. EASING REGULATORY BURDEN WITH RESPECT 
TO CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended— 
(1) by striking ‘‘A report under subsection (k)’’ 
and inserting ‘‘(1) A report under subsection (k)’’; 
and 
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(2) by adding at the end the following new 
paragraph: 
‘‘(2) Not later than 120 days after the date of the 
enactment of the 21st Century Cures Act, the Secretary 
shall identify, through publication in the Federal Register, 
any type of class I device that the Secretary determines 
no longer requires a report under subsection (k) to provide 
reasonable assurance of safety and effectiveness. Upon 
such publication— 
‘‘(A) each type of class I device so identified 
shall be exempt from the requirement for a report 
under subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
(b) CLASS II DEVICES.—Section 510(m) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) 
is amended— 
(1) by striking paragraph (1) and inserting the 
following new paragraph: 
‘‘(1) The Secretary shall— 
‘‘(A) not later than 60 days after the date of 
the enactment of the 21st Century Cures Act— 
‘‘(i) publish in the Federal Register a no-
tice that contains a list of each type of class II 
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device that the Secretary determines no longer 
requires a report under subsection (k) to pro-
vide reasonable assurance of safety and effec-
tiveness; and 
‘‘(ii) provide for a period of not less than 
60 days for public comment beginning on the 
date of the publication of such notice; and 
‘‘(B) not later than 180 days after the date of 
the enactment of 21st Century Cures Act, publish in 
the Federal Register a list representing the Sec-
retary’s final determination with respect to the de-
vices contained in the list published under subpara-
graph (A).’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of 
publication of a list under this subsection,’’ and 
inserting ‘‘1 day after the date of publication of 
the final list under paragraph (1)(B),’’; and 
(B) by striking ‘‘30-day period’’ and in-
serting ‘‘60-day period’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(3) Upon the publication of the final list under para-
graph (1)(B)— 
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