What steps did ReGen take to ensure the integrity of its clinical study?
The clinical trial data submitted to the FDA to obtain 510(k) clearance of the Menaflex device are of the highest quality, and were fully vetted through an independent third-party auditor prior to submission to the FDA. Few if any other sponsors seeking clearance for surgical meshes have submitted clinical data backed by a third-party audit. During the Menaflex clinical study, ReGen conducted an internal audit and identified a number of administrative and procedural issues. These issues did not affect the validity of the data. Nonetheless, ReGen voluntarily notified the FDA. ReGen corrected all identified issues. The company issued new administrative procedures for its clinical study, and contracted with a third party to conduct training at its investigational sites. ReGen retained an independent auditor, which concluded that there were no data integrity issues, and certified the data that became the basis for ReGen’s premarket clearance submission to the FDA.
