In the medical device world, a similar situation occurred with ReGen Biologics for FDA's dubious 510(k) clearance of its Menaflex collagen scaffold, which was often covered in our Washington Wrap-Up column.
But will ReGen get the last laugh? After a contentious years-long review and criticism from various sides about how it was cleared, the device might not be so bad after all. Yesterday, in a rare reassessment of a previously approved medical device, an independent FDA panel of orthopedic experts said that the device is likely safe and effective despite lackluster company data.
"There is evidence of reasonable efficacy, however we have concerns with the level of scientific proof," said panel chairman John Kelly, MD.