11th Circuit rules certain medical devices are not exempt from FDA pre market approval

The United States Court of Appeals for the Eleventh Circuit has issued its opinion in United States v. Endotec, Inc. The central issue on appeal was whether various ankle, knee, and jaw implants manufactured and distributed by Endotec qualified as “custom devices” exempt from the FDC Act's premarket approval requirements. In the district court, FDA had sought a permanent injunction against Endotec and its officers to preclude further manufacture and distribution of such devices without the necessary premarket approval. Siding largely with the company, the District Court held that Endotec’s ankle and jaw implants, but not its knee implants, were exempt “custom devices.” But a couple of days ago the Eleventh Circuit affirmed in part and reversed in part, concurring that the distributed jaw implant was a custom device, but not the knee or ankle implants. The full opinion is available here. The FDA Blog has the full story here.