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Code · CFR · Title 21 — Food and Drugs · Part 821 — Medical Device Tracking Requirements · § 821.4

§ 821.4. Imported devices.

44 words·~1 min read·/us/cfr/t21/s§ 821.4·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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.
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