[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
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]