[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.18]

[Page 109-110]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 812.18  Import and export requirements.

    (a) Imports. In addition to complying with other requirements of 
this part, a person who imports or offers for importation an 
investigational device subject to this part shall be the agent of

[[Page 110]]

the foreign exporter with respect to investigations of the device and 
shall act as the sponsor of the clinical investigation, or ensure that 
another person acts as the agent of the foreign exporter and the sponsor 
of the investigation.
    (b) Exports. A person exporting an investigational device subject to 
this part shall obtain FDA's prior approval, as required by section 
801(e) of the act or comply with section 802 of the act.

[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]