FDA for medical devices

Anyone placing medical devices on the market in the United States works not with the MDR but with the Food and Drug Administration — and its logic is different. Instead of conformity assessment by a notified body, the first question is the regulatory pathway: 510(k) for devices substantially equivalent to one already cleared, De Novo for novel devices of low to moderate risk, PMA for class III with clinical evidence.

On the quality side, the two worlds have recently converged. Since February 2026 the former Quality System Regulation has been replaced by the Quality Management System Regulation, which largely adopts ISO 13485. Anyone operating a certified system is therefore in a considerably better position than before — although the requirements are still not identical, for instance on labelling, complaint handling and reporting obligations.

On top of this come formalities that are easily underestimated: establishment registration and device listing, a US agent for foreign manufacturers, and UDI submission to the GUDID database. The providers listed here support different parts of this — from strategy through submission to local representation.