[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: 21CFR803.12]



[Page 44]

 

                        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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