FDA WARNING_LETTER - MedX Health Corp - June 11, 2014

An FDA inspection of MedX Health Corp. in Mississauga, Ontario, Canada, from June 9-11, 2014, revealed significant violations concerning their SIAscopy Optical Biopsy Scanner. The device was deemed misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, due to the firm's failure to provide required information under 21 CFR Part 803, Medical Device Reporting (MDR). Specifically, the firm failed to develop, maintain, and implement adequate written MDR procedures as mandated by 21 CFR 803.17. Deficiencies included a lack of internal systems for timely event identification and evaluation, an absence of a standardized review process for reportable events, and inadequate systems for the timely transmission of complete MDRs, including instructions for FDA 3500A forms, supplemental reports, 5-day reports, and the correct submission address. The firm's initial response and revised MDR procedure were found inadequate, as several issues persisted. Additionally, the inspection identified nonconformances with the Quality System regulation (21 CFR Part 820), particularly the failure to maintain Device History Records (DHRs) and establish corresponding procedures, as required by 21 CFR 820.184. DHRs for the SIAscopy Optical Biopsy Scanner lacked dates of manufacture and acceptance records. The firm's response regarding DHRs was also deemed inadequate, as no training on the revised procedure was indicated. MedX Health Corp. must provide a comprehensive written response within fifteen business days detailing corrective actions, preventative measures, and a timetable for implementation, addressing these systemic problems. Failure to adequately address these violations could impact federal contracts.