Former Employee of Medical Device Manufacturer Sentenced for Forging FDA Clearance Letters


A Philadelphia-area man was sentenced to 12 months in prison and one year of supervised release for his role in distributing medical devices without U.S. Food and Drug Administration clearance. A regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act by causing the introduction of misbranded and adulterated medical devices into interstate commerce. He admitted that in 2017, he created two false letters that purported to show that FDA had granted clearance to sell two different medical devices. As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report

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