21 CFR 807.85 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices (§ 807.3 To § 807.100) — Premarket Notification Procedures (§ 807.81 To § 807.100) — Exemption from premarket notification.

(a) A device is exempt from the premarket notification requirements of this subpart 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 of the following conditions:

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

(2) 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).

(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:

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

(2) A premarket notification submission was filed by another person.