FDA EIR - Mark R. Newton, M.D. - September 23, 2021

An FDA inspection was conducted at the clinical research site of Dr. Mark R. Newton, Clinical Investigator, located at UnityPoint Health Allen Hospital – Center for Urology in Waterloo, IA, from September 20-23, 2021. This was a For-Cause, pre-market investigational device exemption (IDE) inspection supporting the Premarketing Application for the eCoin® electroceutical device for overactive bladder, regulated by the FDA's Center for Devices and Radiological Health. The inspection revealed five primary observations. Firstly, the enrollment and implantation of study devices in ineligible subjects who did not meet inclusion or had exclusionary criteria. Secondly, major deviations from the investigational plan were initiated without prior approval from the sponsor and Institutional Review Board (IRB). Thirdly, these major deviations were improperly classified as minor, leading to a failure to report them to the IRB as required. Fourthly, Dr. Newton had not completed a financial disclosure form detailing his interests in the study product, nor had he signed an Investigator Agreement. Lastly, annual continuing review reports submitted to the IRB contained inaccurate subject counts for screen fails, lost-to-follow-up individuals, and subjects who completed the study. Dr. Newton and site management acknowledged the findings and committed to providing a written response within 15 business days. Corrective actions include ensuring strict adherence to eligibility criteria, obtaining prior approval for protocol changes, accurately classifying and reporting deviations to the IRB, completing all necessary financial disclosures and investigator agreements, and improving overall documentation practices.