1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
  6. Subpart A - General Provisions
  7. 21 CFR § 821.4
21 CFR § 821.4
Imported devices
June 25, 2020
CFR

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.

Previous
§ 821.3 Definitions

Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.

Designed and built by Tekk Innovations LLC, the makers of the LawStack iPhone app or Android app.

© 2020 Tekk Innovations LLC