The Department of Justice announced that a regulatory affairs specialist for a medical device manufacturer was sentenced to prison for his role in distributing devices that lacked FDA clearance.
The actions led to the illegal sale of two medical devices in the U.S., amounting to tens of thousands of dollars.
The sentence follows last year’s guilty plea by the individual, Peter Stoll III, to one felony count of violating the Federal, Food, Drug and Cosmetic Act. He had been charged with causing the introduction of misbranded and adulterated medical devices into interstate commerce.
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Court documents stated that Stoll’s role with his company, which was not named in the DOJ release, was to submit the necessary documentation to the FDA for the sale of its devices.
However, Stoll admitted that, in 2017, he made a pair of false letters that claimed the FDA had granted clearance for sales of two medical devices. According to the court documents, the devices in question were the ELAN-4 Air Drill, used for high-speed surgical procedures like bone sawing, drilling and cutting, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments.
Stoll was supposed to guide the devices through the FDA’s 510(k) clearance process but admitted he never submitted any required documents for either device. Instead, he made fake letters for both devices with the FDA letterhead and a forged digital signature of an FDA official stating that the devices had been cleared.
Stoll was sentenced to 12 months in prison with an additional year of supervised release.