Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
All TitlesTitle 21Chapter IPart 821Subpart A - Subpart A—General Provisions
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
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