US dispute panel unused since LifeCore Biomedical
This article was originally published in Clinica
Executive Summary
No companies have requested a meeting with the FDA's device dispute resolution panel since LifeCore Biomedical stepped forward as the first guinea pig for that process last September. That surprises Les Weinstein, ombudsman for FDA's Center for Devices and Radiological Health, because the panel recommended that FDA reverse its earlier position and approve LifeCore's PMA for an adhesion protection gel.