[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: 21CFR803.12]

[Page 49]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  803.12  Where and how do I submit reports and additional information?

    (a) You must submit any written report or additional information 
required under this part to FDA, CDRH, Medical Device Reporting, P.O. 
Box 3002, Rockville, MD 20847-3002.
    (b) You must specifically identify each report (e.g., ``User 
Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``10-Day Report'').
    (c) If an entity is confronted with a public health emergency, this 
can be brought to FDA's attention by contacting the FDA Office of 
Emergency Operations (HFA-615), Office of Crisis Management, Office of 
the Commissioner, at 301-443-1240, followed by the submission of an e-
mail to emergency.operations@fda.hhs.gov or a fax report to 301-827-
3333.
    (d) You may submit a voluntary telephone report to the MEDWATCH 
office at 800-FDA-1088. You may also obtain information regarding 
voluntary reporting from the MEDWATCH office at 800-FDA-1088. You may 
also find the voluntary MEDWATCH 3500 form and instructions to complete 
it at http://www.fda.gov/medwatch/getforms.htm.

[70 FR 9519, July 13, 2005, as amended at 71 FR 1488, Jan. 10, 2006]

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