FDA WARNING_LETTER - Lazzaro, Marc, MD - March 23, 2015

This Warning Letter to Dr. Marc Lazzaro of Froedtert Memorial Lutheran Hospital details objectionable conditions observed during an FDA inspection from February 24 to March 23, 2015. The inspection assessed compliance as a clinical investigator in two significant risk clinical studies, IDE (b)(4) and IDE (b)(4), involving investigational devices.

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to conduct the investigation in accordance with the signed agreement and investigational plan (21 CFR 812.110(b)):** Dr. Lazzaro failed to follow exclusion criteria, enrolling subjects with multiple cerebral aneurysms or Modified Rankin Scores greater than or equal to one, potentially increasing their risk. The response was inadequate as it lacked documentation of proposed preventive measures like early internal review, continuing review, and staff training.

2. **Failure to ensure informed consent was obtained in accordance with 21 CFR Part 50 (21 CFR 812.100, 50.20, 50.25, 50.27):** Instances included using incorrect consent form versions, cut-and-pasted CI signatures, and obtaining consent after a subject's death. The response was inadequate, lacking