The slides at the link provided were presented by Jake Romanell RM (AAM) of FDA’s Office of Device Evaluation. Mr. Romanell is responsible for processing all 513(g) requests. These are formal requests for feedback from FDA on which regulations apply to devices that appear unclassified. Companies are increasingly using this process to determine if their products require premarket submissions or are regulated as medical devices in other ways. This is a nonbinding process but at can provide greater confidence in company regulatory decision making.