[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: 21CFR812.19]



[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.  812.19  Address for IDE correspondence.



    If you are sending an application, supplemental application, report, 

request for waiver, request for import or export approval, or other 

correspondence relating to matters covered by this part, you must 

address it to the Center for Devices and Radiological Health, Document 

Mail Center (HFZ-401), Food and Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850. You must state on the outside wrapper of 

each submission what the submission is, for example, an ``IDE 

application,'' a ``supplemental IDE application,'' or a ``correspondence 

concerning an IDE (or an IDE application).''



[65 FR 17137, Mar. 31, 2000]



[[Page 103]]