FDA EIR - Oscar "Howard" Frazier - August 30, 2006

An FDA inspection of Oscar "Howard" Frazier, MD, Principal Investigator, was conducted on August 30, 2006, in Houston, TX. This was an initial, high-priority Center for Devices and Radiological Health (CDRH) IDE Probability Sampling Surveillance Inspection, performed in accordance with FDA Compliance Program 7348.811 for Clinical Investigators. The inspection's primary objective was to evaluate the investigator's conduct and records for a clinical study sponsored by Abiomed, Inc., focusing on compliance with regulatory standards. The review encompassed all regulatory records and correspondence, confirming that all study subjects provided approved informed consent forms and that the Institutional Review Board (IRB) had granted approval prior to subject enrollment. Device accountability and sponsor/monitor correspondence were also examined. Significantly, no FDA Form 483, Inspectional Observations, was issued to Dr. Frazier, indicating no deviations from regulatory requirements were identified during the inspection. No samples were collected, and no refusals were encountered. The inspection concluded without any required immediate actions, with the understanding that the collected report and documents would undergo further review by the Center for Devices and Radiological Health for final classification.