FDA WARNING_LETTER - Vascular Group PLLC - October 24, 2011

An FDA inspection of The Vascular Group PLLC, led by Dr. Manish Mehta, from September 27 to October 24, 2011, revealed a serious violation of 21 CFR Part 812 concerning Investigational Device Exemptions. The inspection aimed to ensure compliance as a sponsor in the clinical study (b)(4) and protect human subjects. The primary violation identified was the failure to submit an Investigational Device Exemption (IDE) application to the FDA and obtain both IRB and FDA approval before allowing subjects to participate in the investigation, as required by 21 CFR 812.40 and 21 CFR 812.42. Specifically, the firm administered an investigational device for percutaneous transluminal angioplasty on two human subjects in the (b)(4) study, which investigated angioplasty balloon devices for an unapproved use in treating extracranial venous obstructive lesions in Multiple Sclerosis patients. These devices were deemed significant risk devices under 21 CFR 812.3(m), necessitating an IDE application and FDA approval. The firm's response, stating a halt to enrollment, was deemed inadequate as it failed to acknowledge the fundamental requirement for IDE and FDA approval to ensure subject safety and prevent recurrence. The FDA requires documentation of corrective actions, including projected completion dates and a monitoring plan, within 15 working days to prevent further regulatory action.