[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.18]

[Page 102]
 
                        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 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]