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Home » Former Devicemaker Employee Pleads Guilty to Forging 510(k) Clearances
Former Devicemaker Employee Pleads Guilty to Forging 510(k) 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.