21 CFR § 821.4 - Imported devices.

---
identifier: "/us/cfr/t21/s821.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 821.4 - Imported devices."
title_number: 21
title_name: "Food and Drugs"
section_number: "821.4"
section_name: "Imported devices."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "821"
part_name: "MEDICAL DEVICE TRACKING REQUIREMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374."
regulatory_source: "58 FR 43447, Aug. 16, 1993, unless otherwise noted."
cfr_part: "821"
---


# 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.