[zomg]

another confounding problem is how the FDA classifies and approves devices for clearance. most regulatory strategies have the company strive to find a predicate and prove they are substantially equivalent (SESE), which generally means a class II device, which does NOT require clinical data for clearance.

it's frustrating that the article uses the term "approve" which is specific to PMA devices (class III), whereas class II devices are "cleared" by the FDA.

- a medical device executive