[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

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]