21 CFR 821.4

§ 821.4 Imported devices.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 821.4, § 821.4 Imported devices, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88908
Permanent ID: ys:prov:88908@1
SHA-256: 7e855e7c5a6233d9ed67bcd24e28acbb1acf71f00024f9134a3a9ea1bf2093e1

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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.