§ 821.20 Devices subject to tracking

(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 premarket 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.

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What FDA inspectors cite under § 821.20

Form FDA 483 observations citing this section, fiscal years 2013–2020 (Devices).

• Failure to track 2

Amendment history

Federal Register documents that created or amended this section.

• 67 FR 5951 8 Feb 2002