[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
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 to submit reports.

    (a) Any written report or additional information required under this 
part shall be submitted to: Food and Drug Administration, Center for 
Devices and Radiological Health, Medical Device Reporting, PO Box 3002, 
Rockville, MD 20847-3002.
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
    (c) If an entity is confronted with a public health emergency, this 
can be brought to FDA's attention by contacting the FDA Emergency 
Operations Branch (HFC-162), Office of Regional Operations, at 301-443-
1240, and should be followed by the submission of a FAX report to 301-
443-3757.
    (d) A voluntary telephone report may be submitted to, or information 
regarding voluntary reporting may be obtained from, the MEDWATCH hotline 
at 800-FDA-1088.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]