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# Peter Stoll Guilty on Medical Device Felony Count
- URL: https://www.fdaweb.com/peter-stoll-guilty-on-medical-device-felony-count/
- Published: 2023-07-21T12:00:00.000Z
- Updated: 2026-09-14T18:45:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154930

Former medical device regulatory affairs specialist **Peter Stoll III** has pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce.

According to court documents, Stoll was responsible for making 510(k) submissions to the agency that were required before the company could sell its medical devices. “In pleading guilty, Stoll admitted that in 2017 he created two false letters that purported to show that FDA had granted clearance to sell two different medical devices,” a Justice Department [release](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/employee-medical-device-manufacturer-pleads-guilty-forging-two-fda-clearance-letters-medical-devices?ref=fdaweb.com) says. “As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.”

Stoll admitted he never submitted a 510(k) for two devices that were marketed. “Instead, Stoll created a fraudulent letter using FDA letterhead and bearing the forged digital signature of an FDA official that falsely stated that FDA had cleared the ELAN-4 Air to be marketed,” the government contends. “Stoll later created another, similarly fraudulent letter on FDA letterhead for the SterilContainer JS Series medical device.” Both devices have been subsequently recalled by Aesculap Implant Systems.

Stoll is scheduled to be sentenced on 11/7\. He faces up to three years’ in prison, a one-year period of supervised release, and a $250,000 fine.