FDA EIR - Perseon Corporation - November 30, 2016

Perseon Corp., a medical device manufacturer based in Salt Lake City, UT, underwent a routine FDA inspection from November 29-30, 2016. This Level I inspection, conducted under Compliance Program 7382.845 for Medical Device Manufacturers, specifically evaluated the company's Corrective and Preventive Action (CAPA) and Design Controls subsystems for its Class II MicroThermX Microwave Ablation System. This device is designed for electrosurgical cutting and coagulation using high-frequency electrical current. Notably, the inspection identified no objectionable conditions or significant violations. As a result, the FDA did not issue a Form FDA-483, “Notice of Inspectional Observations,” to Perseon Corp. While no formal violations were cited, Universal Device Identification (UDI) labeling rules were discussed, and management affirmed their ongoing efforts to achieve compliance for all new devices. The inspection closed without any required official actions or samples collected, reflecting a satisfactory outcome for the company.