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FDA Dings Medical Device Trial for Lack of IRB Review and Monitoring
(Thursday, March 21, 2024) A medical device company had to suspend its ongoing pivotal clinical trial and may lose the data collected in the trial so far because of major violations of Good Clinical Practices (GCP) found during an FDA audit. The Warning Letter issued to the company looks like a lesson in the basics of GCP compliance for device clinical trials. The fact this is a trial conducted under an Investigational Device Exemption (IDE) makes these findings even more egregious. All medical device clinical trials must follow 21 CFR 812 regulations which are quite similar to the drug clinical trial requirements described in 21 CFR 312, along with GCP. This includes getting IRB approval before initiating the trial and keeping the IRB approval current by getting ongoing reviews, selecting qualified investigators, ensuring that the investigators are always compliant with the protocol, monitoring the conduct of the study, and maintaining good documentation. FDA found that Nobles Medical Technology of California did not do any of those. The sponsor was unable to present documentation of current IRB approval, investigator agreements and training, written monitoring plan, ensure that the investigators had no conflict of interest, and monitor the study conduct properly. FDA found instances where the investigators did not even sign the CRF pages for eight to twelve months after monitoring visits. It seems that the sponsor was not aware of the basic GCP requirements. Perhaps the sponsor assumed that since this was a medical device trial, it did not need to follow quality practices like those for clinical trials with drugs. The clinical trial is currently suspended while the company seeks to address the FDA findings. All clinical trials must follow GCP along with the applicable FDA regulations. This warning letter should be used for GCP training to show what not to do when conducting a clinical trial. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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