eCFR Reference Browser

---

title: "21 CFR §821.4"

source: "https://www.ecfr.gov/current/title-21/section-821.4"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "821"

part_subject: "MEDICAL DEVICE TRACKING REQUIREMENTS"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "821.4"

section_subject: "Imported devices."

cfr_reference: "21 CFR 821.4"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§821.4 - Imported devices.