II 

117TH CONGRESS 

1ST SESSION S. 3416 

To expand the enforcement authority of the Food and Drug Administration 

with respect to counterfeit devices. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 16, 2021 

Mr. MURPHY (for himself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To expand the enforcement authority of the Food and Drug 

Administration with respect to counterfeit 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. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Patients 

5 from Counterfeit Medical Devices Act’’. 

6 SEC. 2. EXPANDING ENFORCEMENT AUTHORITY AND PEN7 ALTIES FOR COUNTERFEIT DEVICES. 

8 (a) PROHIBITED ACTS.—Section 301 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend10 ed by adding at the end the following: 


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1 ‘‘(fff)(1) Forging, counterfeiting, simulating, or false2 ly representing, or without proper authority using any 

3 mark, stamp, tag, label, or other identification device upon 

4 any device or container, packaging, or labeling thereof so 

5 as to render such device a counterfeit device. 

6 ‘‘(2) Making, selling, disposing of, or keeping in pos7 session, control, or custody, or concealing any punch, die, 

8 plate, stone, or other thing designed to print, imprint, or 

9 reproduce the trademark, trade name, or other identifying 

10 mark, imprint, or device of another or any likeness of any 

11 of the foregoing upon any device or container, packaging, 

12 or labeling thereof so as to render such device a counter13 feit device. 

14 ‘‘(3) The doing of any act which causes a device to 

15 be a counterfeit device, or the sale or dispensing, or the 

16 holding for sale or dispensing, of a counterfeit device.’’. 

17 (b) PENALTIES.—Section 303 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 333) is amended— 

19 (1) in subsection (b)(8), by inserting ‘‘, or who 

20 violates section 301(fff)(3) by knowingly making, 

21 selling or dispensing, or holding for sale or dis22 pensing, a counterfeit device,’’ after ‘‘a counterfeit 

23 drug’’; and 

24 (2) in subsection (c), by inserting ‘‘; or (6) for 

25 having violated section 301(fff)(2) if such person 


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1 acted in good faith and had no reason to believe that 

2 use of the punch, die, plate, stone, or other thing in3 volved would result in a device being a counterfeit 

4 device, or for having violated section 301(fff)(3) if 

5 the person doing the act or causing it to be done 

6 acted in good faith and had no reason to believe that 

7 the device was a counterfeit device’’ before the pe8 riod. 

9 (c) SEIZURE.—Section 304(a)(2) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is 

11 amended— 

12 (1) by striking ‘‘, and (E)’’ and inserting ‘‘, 

13 (E)’’; and 

14 (2) by inserting ‘‘, (F) Any device that is a 

15 counterfeit device, (G) Any container, packaging, or 

16 labeling of a counterfeit device, and (H) Any punch, 

17 die, plate, stone, labeling, container, or other thing 

18 used or designed for use in making a counterfeit de19 vice or devices’’ before the period. 

Æ 


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