FDA WARNING_LETTER - American Association of Acupuncture and Bio-Energetic Medicine - November 05, 2010

This FDA Warning Letter, dated December 22, 2010, addresses objectionable conditions observed during an FDA inspection of the American Association of Acupuncture and Bio-Energetic Medicine (AAABEM) Institutional Review Board (IRB) from October 25 to November 5, 2010. The inspection aimed to ensure compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions), and to protect human subjects.

The inspection revealed several violations: 1. **Failure to ensure informed consent (21 CFR 56.111(a)(4))**: The IRB approved a protocol where the investigational device was used before informed consent was obtained. The IRB's corrective action of revising the protocol was deemed inadequate as it did not describe how recurrence would be prevented. 2. **Failure to follow written procedures for review and reporting (21 CFR 56.108(a))**: * The IRB did not follow its protocol for sending semi-annual progress report reminders, delaying the second request. * Investigator semi-annual progress reports consistently omitted required elements, such as study progress summaries, results, unexpected findings, investigator/site numbers, and details on consent for illiterate/non-English speaking subjects. The IRB's revised form still missed two elements,