21 CFR 821.4 - Imported devices.

Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart A [§ 821.1 - § 821.4]

§ 821.4 - Imported devices.

For purposes of this part, the importer of a tracked device shall be considered the manufacturer and shall be required to comply with all requirements of this part applicable to manufacturers. Importers must keep all information required under this part in the United States.

authority: 21 U.S.C. 331,351,352,360,360e,360h,360i,371,374

source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.

cite as: 21 CFR 821.4