FDA WARNING_LETTER - Wakai, Ronald, Ph. D., Clinical Investigator - August 22, 2014

The FDA issued a Warning Letter to Ronald Wakai, Ph.D., of UW Biomagnetism Lab, following an August 2014 inspection of his clinical site. The inspection, concerning the "(b)(4) Investigational Device Exemptions" study, revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key deficiencies included the failure to conduct the investigation according to the approved plan and regulations, specifically enrolling subjects who met exclusion criteria (e.g., with implants), not completing eligibility forms pre-procedure, and not obtaining IRB approval for protocol revisions [21 CFR 812.110(b)]. The firm also failed to ensure informed consent was obtained using the correct IRB-approved versions [21 CFR 50.27(a)] and did not maintain accurate, complete, and current records, leading to missing documentation of inclusion/exclusion criteria, correspondence, and inconsistent subject data [21 CFR 812.140(a)(1), (a)(3)]. Furthermore, as a sponsor, Dr. Wakai failed to ensure proper monitoring of the investigation [21 CFR 812.40]. These issues compromised data integrity and increased risks to subjects, particularly pregnant women. The FDA deemed the initial response inadequate, requiring detailed corrective and preventive action plans, root cause analyses, documentation of revised policies, training, and re-consenting efforts, with a 15-working-day deadline. Failure to comply could lead to regulatory action, including disqualification. The Health Sciences IRB has already suspended the studies.