Did the FDA’s warning letter to ReGen criticize the clinical trial data?
No. In fact, after an internal audit, ReGen identified administrative issues from its clinical trial and voluntarily disclosed them to the FDA. The FDA responded by inspecting ReGen and two of the 16 investigational sites conducting the clinical trial. ReGen received a warning letter and the two sites selected by FDA did not. The warning letter identified that ReGen did not train on new procedures developed to deal with previously identified administrative issues. ReGen responded to the FDA’s concern and hired a third party firm to provide training; the FDA determined that this response constituted adequate correction. Additionally, ReGen retained an independent third party to audit 100 percent of the clinical data. The audit showed that there were no data integrity issues, and the auditors certified the data. The FDA reviewed the audit results and the Center for Devices’ Integrity Officer authorized the use of the data in ReGen’s 510(k) submission.
