Did the FDA Impose Device-Specific Requirements on the Evergreen Balloon Catheter?
Riegel argues that the FDA never imposed device-specific requirements on the Evergreen Balloon Catheter. See Brief for Petitioner at 24. According to Riegel, “device-specific requirements” are predetermined manufacturing instructions included in FDA regulations. In this case, the FDA never issued specific instructions about how manufacturers should design catheters. See id. The PMA only determined that the Evergreen Balloon Catheter met minimal thresholds of safety and effectiveness, and therefore in Riegel’s view state law should not be barred from further protecting consumers. See id. For example, the catheter’s PMA contrasts with the FDA regulations setting performance standards for certain lasers: “Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 microns . . .” Id. at 28. While manufacturers of medical laser devices must abide by predetermined requirements, Medtronic designed the catheter without input from the FDA. Se
