Title: Protecting Patients from Counterfeit Medical Devices Act
Policy area: Health

Summary:
Protecting Patients from Counterfeit Medical Devices Act
This bill expands provisions in the Federal Food, Drug, and Cosmetic Act pertaining to counterfeit drugs to also cover counterfeit medical devices and addresses related issues. (Current law prohibits trafficking in counterfeit goods generally.)
The bill prohibits certain actions, such as selling counterfeit devices or forging labels to make counterfeit medical devices. An individual or entity that makes or sells a counterfeit medical device shall be subject to fines, imprisonment for up to 10 years, or both.
Counterfeit medical devices, packaging and labeling for counterfeit medical devices, and items used for making counterfeit medical devices may be seized pursuant to a federal court proceeding.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3416 Introduced in Senate (IS)]

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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.

    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 ``Protecting Patients from Counterfeit 
Medical Devices Act''.

SEC. 2. EXPANDING ENFORCEMENT AUTHORITY AND PENALTIES FOR COUNTERFEIT 
              DEVICES.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp, tag, 
label, or other identification device upon any device or container, 
packaging, or labeling thereof so as to render such device a 
counterfeit device.
    ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark, imprint, or device of another or 
any likeness of any of the foregoing upon any device or container, 
packaging, or labeling thereof so as to render such device a 
counterfeit device.
    ``(3) The doing of any act which causes a device to be a 
counterfeit device, or the sale or dispensing, or the holding for sale 
or dispensing, of a counterfeit device.''.
    (b) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended--
            (1) in subsection (b)(8), by inserting ``, or who violates 
        section 301(fff)(3) by knowingly making, selling or dispensing, 
        or holding for sale or dispensing, a counterfeit device,'' 
        after ``a counterfeit drug''; and
            (2) in subsection (c), by inserting ``; or (6) for having 
        violated section 301(fff)(2) if such person acted in good faith 
        and had no reason to believe that use of the punch, die, plate, 
        stone, or other thing involved would result in a device being a 
        counterfeit device, or for having violated section 301(fff)(3) 
        if the person doing the act or causing it to be done acted in 
        good faith and had no reason to believe that the device was a 
        counterfeit device'' before the period.
    (c) Seizure.--Section 304(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(a)(2)) is amended--
            (1) by striking ``, and (E)'' and inserting ``, (E)''; and
            (2) by inserting ``, (F) Any device that is a counterfeit 
        device, (G) Any container, packaging, or labeling of a 
        counterfeit device, and (H) Any punch, die, plate, stone, 
        labeling, container, or other thing used or designed for use in 
        making a counterfeit device or devices'' before the period.
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