510(k) vs PMA: choosing an initial FDA pathway
Article overview
Overview
A first pass from class, predicates, and novelty. Confirm it on the FDA classification database and with counsel.
Early on, a team wants a working hypothesis: 510(k), De Novo, or PMA. Start with the device class, whether a legally marketed predicate has the same intended use, and whether the technology raises new questions of safety and effectiveness.
Worked example. A non-implantable Class II vital-signs monitor, same intended use and similar technology to a marketed device. The first hypothesis is a 510(k), with bench and clinical performance testing that follows the predicate and the relevant standards. If there is no credible predicate and the risk is moderate, De Novo may fit.
Common mistakes. Assuming every Class I device is exempt from 510(k). Calling a predicate similar when the intended use is different. Skipping a Q-Sub when the test plan or the predicate is genuinely uncertain.
Structure the first hypothesis: https://nexamedtech.com/tools/fda-pathway-picker