After pleading guilty to forging two FDA clearance letters, a former employee of a medical device company was sentenced to one year of prison, the Justice Department said Jan. 24.
Peter Stoll III, 35, pleaded guilty last year of creating two false FDA medical device clearance letters in 2017, which resulted in his company selling tens of thousands of dollars' worth of items in the U.S.
At the time, Mr. Stoll was a regulatory affairs specialist at Aesculap Implant Systems, which ended up recalling the two products — a surgical drill used for bone drilling and a reusable sterilization container for medical instruments — in 2017.
Mr. Stoll admitted he never submitted any 510(k) documents to the FDA for either device, and he created fraudulent market clearance letters using the agency's letterhead and a forged digital signature of an FDA official.
He was also sentenced to one year of supervised release, according to the Justice Department.