21 CFR 821.4 - Imported devices.
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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.
Title 21 published on 2014-04-01.
No entries appear in the Federal Register after this date, for 21 CFR Part 821.