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 certain class I and class II devices. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. EASING REGULATORY BURDEN WITH RESPECT 

4 TO CERTAIN CLASS I AND CLASS II DEVICES. 

5 (a) CLASS I DEVICES.—Section 510(l) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 

7 amended— 

8 (1) by striking ‘‘A report under subsection (k)’’ 

9 and inserting ‘‘(1) A report under subsection (k)’’; 

10 and 


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1 (2) by adding at the end the following new 

2 paragraph: 

3 ‘‘(2) Not later than 120 days after the date of the 

4 enactment of the 21st Century Cures Act, the Secretary 

5 shall identify, through publication in the Federal Register, 

6 any type of class I device that the Secretary determines 

7 no longer requires a report under subsection (k) to provide 

8 reasonable assurance of safety and effectiveness. Upon 

9 such publication— 

10 ‘‘(A) each type of class I device so identified 

11 shall be exempt from the requirement for a report 

12 under subsection (k); and 

13 ‘‘(B) the classification regulation applicable to 

14 each such type of device shall be deemed amended 

15 to incorporate such exemption.’’. 

16 (b) CLASS II DEVICES.—Section 510(m) of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) 

18 is amended— 

19 (1) by striking paragraph (1) and inserting the 

20 following new paragraph: 

21 ‘‘(1) The Secretary shall— 

22 ‘‘(A) not later than 60 days after the date of 

23 the enactment of the 21st Century Cures Act— 

24 ‘‘(i) publish in the Federal Register a no25 tice that contains a list of each type of class II 


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1 device that the Secretary determines no longer 

2 requires a report under subsection (k) to pro3 vide reasonable assurance of safety and effec4 tiveness; and 

5 ‘‘(ii) provide for a period of not less than 

6 60 days for public comment beginning on the 

7 date of the publication of such notice; and 

8 ‘‘(B) not later than 180 days after the date of 

9 the enactment of 21st Century Cures Act, publish in 

10 the Federal Register a list representing the Sec11 retary’s final determination with respect to the de12 vices contained in the list published under subpara13 graph (A).’’; 

14 (2) in paragraph (2)— 

15 (A) by striking ‘‘1 day after the date of 

16 publication of a list under this subsection,’’ and 

17 inserting ‘‘1 day after the date of publication of 

18 the final list under paragraph (1)(B),’’; and 

19 (B) by striking ‘‘30-day period’’ and in20 serting ‘‘60-day period’’; and 

21 (3) by adding at the end the following new 

22 paragraph: 

23 ‘‘(3) Upon the publication of the final list under para24 graph (1)(B)— 


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1 ‘‘(A) each type of class II device so listed shall 

2 be exempt from the requirement for a report under 

3 subsection (k); and 

4 ‘‘(B) the classification regulation applicable to 

5 each such type of device shall be deemed amended 

6 to incorporate such exemption.’’. 

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