GroundRules
21 CFR 821.4: Imported devices.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
- Subpart A—General Provisions
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON