FDA premarket submission number

Manufacturers enter this number when they list a device, which links the listing to the marketing authorization. Devices that are exempt from premarket review are listed without one.

FDA premarket submission number means the number assigned by FDA to a premarket device submission, such as a Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); New Drug Application (NDA); Biologics License Application (BLA); de novo classification petition; or Premarket Notification (510(k)).

21 CFR, 807.3