10513.1 A device is exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if the device intended for introduction into commercial distribution is not generally available in finished form for purchase and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and the device meets one (1) of the following conditions:

(a) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or

(b) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).

10513.2 A distributor who places a device into commercial distribution for the time under his own name and a re-packager who places his or her own name on a device and does not change any other labeling or otherwise affect the device shall be exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if:

(a) The device was in commercial distribution before May 28, 1976; or

(b) Another person filed the premarket notification on submission.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).