Protecting Patients from Counterfeit Medical Devices Act

To expand the enforcement authority of the Food and Drug Administration with respect to counterfeit devices. 1. Short title This Act may be cited as the Protecting Patients from Counterfeit Medical Devices Act 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 (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 (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, a counterfeit drug (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 (c) Seizure Section 304(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334(a)(2) (1) by striking , and (E) , (E) (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

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.