21 C.F.R. § 821.4 Imported devices.
Title 21 - Food and Drugs
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: Food and Drugs
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
Subpart A—General Provisions
§ 821.4 Imported devices.
