The DOJ announced that Peter Stoll III, former employee of a medical device company located in Pennsylvania, will serve prison time for falsifying U.S. Food and Drug Administration (FDA) documents.

Stoll was employed as a regulatory affairs specialist, and he was responsible for completing the FDA’s Premarket Notification 510(k) clearance process before the company could market and sell its medical devices. Companies are required to submit documentation to demonstrate that their device is as safe and effective as to be “substantially equivalent” to a legally marketed device. Devices should not be marketed and sold until the company receives an order declaring the devices “substantially equivalent,” which usually takes about 90 days from the date of submission.

Instead of completing the 510(k) processes for two of his company’s medical devices, the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing and drilling, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments, Stoll admitted to falsifying FDA clearance documents.  In 2017, Stoll created fraudulent 510(k) paperwork, on FDA’s official letter head, and included a forged FDA official signature. Based on the deceptive documentation, the medical device company sold tens of thousands of dollars’ worth of devices throughout the country.

Last year Stoll pleaded guilty to one 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 turn, Stoll was sentenced to 12 months in prison and one year of supervised release by U.S. District Judge Joseph F. Leeson.  When Stoll’s sentence was announced,  Assistant Commissioner for Criminal Investigations Justin D. Green of the FDA commented that  “[a] medical device distributed without FDA clearance can put patients at risk. Our office will aggressively pursue those who place patients at risk by failing to follow the law.”

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