21 C.F.R. § 821.20 Devices subject to tracking.
Title 21 - Food and Drugs
(a) A manufacturer of any class II or class III device that fits within one of the three criteria within §821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to that manufacturer. (b) When responding to premarket notification submissions and remarket approval applications, FDA will notify the sponsor by issuing an order that states that FDA believes the device meets the criteria of section 519(e)(1) of the act and, by virtue of the order, the sponsor must track the device. [67 FR 5951, Feb. 8, 2002]
Title 21: Food and Drugs
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
Subpart B—Tracking Requirements
§ 821.20 Devices subject to tracking.
