When does a federal agency have "inherent authority"? Not in this case, according to the D.C. Circuit Court in Ivy Sports Medicine v. Burwell.
ReGen Biologics made a device called a Collagen Scaffold for use in knee surgery. ReGen began the process of obtaining FDA approval for the device in 2004. In 2006, several members of Congress from New Jersey, where ReGen is based, expressed concern about the review process. In 2008, the FDA ultimately classified the Collagen Scaffold as a Class II device, which requires less regulation.
But months after getting the approval, a Wall Street Journal article alleged "political pressure" in the Collagen Scaffold approval process. Members of Congress expressed umbrage (no doubt in the most public ways possible) and the FDA investigated, finding that ReGen was a little too close to FDA officials, who didn't follow standard procedures when approving the Collagen Scaffold. The FDA summarily reclassified the device as a Class III device, which had the practical effect of making it unmarketable unless ReGen applied all over again.