(a) Updating of device listing information is required if an additional establishment begins to engage in any of the activities described in 807.3(d) with respect to a listed device, such as manufacturing, developing specifications, repackaging, relabeling, or otherwise processing the device. Updating of the listing is also required if an establishment begins performing another activity on or to the device, or ceases to perform an activity on or to the device that had previously been identified on the device listing.
(b) An owner or operator shall create a new device listing using the FDA electronic device registration and listing system:
(1) If introducing into commercial distribution an exempt device identified with a product code that is not currently listed by the owner or operator; or
(2) If introducing into commercial distribution a non-exempt device with an FDA premarket submission number that is not currently listed by the owner or operator.
(c) All device listings for foreign establishments must be submitted before the device may be imported or offered for import into the United States.
(d) An owner or operator who discontinues commercial distribution of a device shall discontinue the device listing using the FDA electronic device registration and listing system. A device listing is considered discontinued if:
(1) All devices under an exempt product code have been discontinued or
(2) All devices associated with an FDA premarket submission number have been discontinued.
(e) If commercial distribution of a discontinued device is resumed, the owner or operator must reactivate the previously-discontinued listing using the electronic device registration and listing system. Any changes to the listing information for the product that is the subject of the listing such as a new establishment, new activity, or new proprietary name must be made using the electronic device registration and listing system at the time the listing is reactivated.
(f) FDA will assign one listing number for all devices exempt from premarket notification requirements under a single product code. For products not exempt from premarket notification requirements, a single listing number will be assigned by FDA for each FDA premarket submission number.
[77 FR 45943, Aug. 2, 2012]