Former Employee Pleads Guilty to Forging 510(k) Device Clearances

A regulatory affairs specialist for an eastern Pennsylvania medical device company has pled guilty to fabricating documents on FDA letterhead representing that two of his company’s products had received 510(k) clearances when, in fact, he had never made any submissions for the devices.

According to the Department of Justice (DOJ), Peter Stoll III was responsible for making submissions to the FDA for 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, both produced by Aesculap, a division of B. Braun America.

Stoll admitted that he never submitted any 510(k) documents to the FDA for either device, the DOJ said, but instead created fraudulent 510(k) clearance letters in 2017 using FDA letterhead with a forged digital signature of an FDA official.

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