Former Regulatory Affairs Employee Pleads Guilty to Faking FDA 510(k) Clearances for Two Devices

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Former Regulatory Affairs Employee Pleads Guilty to Faking FDA 510(k) Clearances for Two Devices

Dennis Tosh

July 26, 2023 at 05:24 PM EST

A former regulatory affairs specialist for a medical device manufacturer in Pennsylvania pleaded guilty July 20 to a criminal charge related to falsely telling his firm that he had secured FDA premarket notification (510(k)) clearance for two of the company’s devices. The deception — which included forging agency 510(k) clearance letters — led the manufacturer to market the pr... Read More

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Former Regulatory Affairs Employee Pleads Guilty to Faking FDA 510(k) Clearances for Two Devices

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