Ivy Sports Medicine, LLC v. Sylvia Mathews Burwell

Opinion for the Court filed by Circuit Judge KAVANAUGH, with whom Circuit Judge GRIFFITH joins.

Dissenting opinion filed by Circuit Judge PILLARD.

KAVANAUGH, Circuit Judge:

This case concerns the Food and Drug Administration’s regulation—and subsequent re-regulation—of a medical device called the Collagen Scaffold, an absorbable surgical mesh that is designed for use in knee-replacement surgeries. In December 2008, the manufacturer of the scaffold, ReGen Biologies, obtained FDA clearance to market the device. FDA’s clearance of the scaffold soon came under fire in the press and from some Members…