Companies that Fought FDA and Won
Medtech companies that have ever gone toe-to-toe with regulators let out a cheer this year when two from their ranks won significant battles versus FDA.
In June, Electromedical Products International Inc., a maker of cranial electrotherapy stimulation (CES) devices, prevailed in its nearly quarter-century campaign to convince FDA to down-classify CES devices from Class III to Class II.
Then, in September, the Washington DC Court of Appeals ruled in favor of the plaintiff in Ivy Sports v. Burwell. Ivy Sports had been fighting a decision by the agency to rescind market clearance for the Collagen Scaffold surgical mesh that forced its predecessor company, ReGen Biologics, into bankruptcy in 2011.
These David-versus-Goliath victories provided a welcome dose of...