Table 2.

Terminology defined: US regulatory pathways.

Term	Definition
Cleared	FDA clears a medical device to be marketed after a manufacturer submits a 510 (k) marketing application and demonstrates substantial equivalency to a predicate device, as well as follows general controls, such as good manufacturing practices and special controls. This is a Class II medical device submission pathway.
De novo request granted	Manufacturers submit a de novo request (i.e., the marketing application) for Class II medical devices for which there is no predicate device. Upon review, FDA grants the request for the medical device to be a Class II device, and the medical device is considered cleared for marketing. This pathway is typically more rigorous than the 510 (k) pathway, but less rigorous than that for a Class III device.
Approved	Class III medical devices go through a rigorous and substantial review when manufactures submit a PMA application for FDA review. When a device is found to be safe and effective, FDA approves it for marketing.

Specific terminology defines which FDA submission pathway a medical device has gone through. For manufacturers, each term has implications for device development.