A Philadelphia-area man pleaded guilty for his role in distributing medical devices without US Food and Drug Administration (FDA) clearance, the Department of Justice announced. Peter Stoll III, 34, pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce, in violation of 21 United States Code, Section 331(a) and 331(a)(2). According to court documents, Stoll was a regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania and was responsible for making submissions to the FDA that were required before the company could sell its medical devices. In pleading guilty, Stoll 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.
