FDA WARNING_LETTER - Perez-Cruet, Miguelangelo J., M.D., M.S. - December 02, 2009

On March 2, 2010, the FDA issued a Warning Letter to Dr. Miguelangelo J. Perez-Cruet, M.D., M.S., following an inspection from September 14 to December 2, 2009. The inspection assessed compliance with federal regulations for clinical studies involving an investigational device, (b)(4).

The inspection revealed violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key deficiencies included:

1. **Failure to obtain informed consent correctly (21 CFR 50.20, 50.27(a), 812.100):** Three subjects in the (b)(4) study received an incorrect informed consent form with differing follow-up times and information on device implantation. One subject signed a form indicating device implantation but received a control device. The response regarding corrective actions was deemed inadequate.

2. **Failure to conduct investigations according to the plan and regulations (21 CFR 812.100, 812.110(b)):** * **(b)(4) Study:** Seven out of 25 subjects were enrolled despite meeting exclusion criteria (e.g., (b)(4), (b)(4)). Two major complications were not reported within the required timeframe (5 days,