Ex-employee of medical device manufacturer pleads guilty to forging FDA clearance letters

A man from the Philadelphia area pleaded guilty to distributing medical devices without FDA clearance. 

Peter Stoll III was a regulatory affairs specialist at a medical device manufacturer in Pennsylvania, according to a July 20 news release from the Justice Department. There, he was responsible for making the required submissions to the FDA before the company could sell its medical devices.

Mr. Stoll admitted that in 2017 he created two false letters purporting  the FDA granted clearance to sell two separate medical devices, which resulted in the company illegally selling thousands of dollars' worth of medical devices. The two devices were a high-speed surgical drill used for bone cutting, sawing, and drilling and a reusable sterilization container for medical instruments.

Mr. Stoll faces a maximum penalty of three years in prison, a one-year period of supervised release, a $250,000 fine and a $100 special assessment.

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