Risk-Averse FDA Strangles 510(k) Process, New Citizen’s Petition Charges

A citizen’s petition filed by Minneapolis law firm DuVal & Associates challenges several aspects of the 510(k) process, charging that current practices effectively overstep CDRH’s statutory boundaries and insert the agency into the practice of medicine. Alleged FDA policies called into question include: “stage-gating” 510(k) reviews and wrongly bumping devices that would be proven equivalent through an in-depth review to the de novo path, forcing industry to gather and submit more information than is required by statute; ignoring least-burdensome requirements in requesting additional information before clearing products; and applying an inappropriately narrow definition of general versus specific intended use.
Devices & Diagnostics Letter