EndoGastric Solutions, Inc. – FDA Warning Letter, Feb 29, 2012

On June 8, 2012, the FDA issued a Warning Letter to Endogastric Solutions, Inc., following an inspection from February 10-29, 2012, regarding their clinical study, "A Randomized Controlled Trail of (b)(4) Patients to Reduce Regained Weight," IDE (b)(4), involving the (b)(4) investigational device. The inspection aimed to ensure compliance with federal regulations, data validity, and human subject protection.

The FDA identified several violations of 21 CFR Part 812 - Investigational Device Exemptions. Endogastric Solutions failed to provide investigators with necessary information, ensure proper monitoring, and promptly inform the IRB and FDA of significant new information (21 CFR 812.40). Specifically, monitoring visits at Site 01 and Site 02 were significantly delayed, exceeding protocol specifications. The firm also failed to promptly notify the IRB (notified April 2011) and FDA (not notified at all) when enrollment was put on hold in November/December 2010 due to questionable device effectiveness. Additionally, Endogastric Solutions did not provide for (b)(6) for clinical investigators.

Furthermore, Endogastric Solutions failed to notify FDA within 30 working days of the termination of the significant risk device investigation (21 CFR 812.150(b)(7)). The study was "cancelled