[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR821.4]

[Page 153]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 821.4  Imported devices.

    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.