[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.19]

[Page 107-108]
 
                        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.

    (a) 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 
send the submission to the appropriate address as follows:
    (1) For devices regulated by the Center for Devices and Radiological 
Health, send it to the Document Mail Center (HFZ-401), Center for 
Devices and Radiological Health, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, send it to the Document Control Center (HFM-99), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research,

[[Page 108]]

send it to Central Document Control Room, Center for Drug Evaluation and 
Research, Food and Drug Administration, 5901-B Ammendale Rd., 
Beltsville, MD 20705-1266.
    (b) 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).''

[71 FR 42048, July 25, 2006]