How FDA assigns drug-device, biologic-device, and drug-biologic combination products to CDER, CBER, or CDRH: primary mode of action, the Request for Designation process, and how sponsors should plan around jurisdiction early.
Every medical device company reaches the same fork in the road: which FDA pathway fits the device in front of them. Choosing wrong doesn’t just cost time — it can mean building an entire evidence package for the wrong evidentiary standard, then rebuilding it under regulatory pressure. This article walks through how the three primary pathways — 510(k), De Novo, and PMA — actually differ in practice, and how sponsors should be thinking about the decision in 2026. The Core Disti
