[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: 21CFR803.11]

[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. 803.11  Obtaining the forms.

    User facilities and manufacturers must submit all reports of 
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an 
electronic equivalent as approved under Sec. 803.14. This form and all 
other forms referenced in this section can also be obtained from the 
Consolidated Forms and Publications Office, Washington Commerce Center, 
3222 Hubbard Rd., Landover, MD 20875; from the Food and Drug 
Administration, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7240; from the Division of Small Manufacturers Assistance, 
Office of Health and Industry Programs, Center for Devices and 
Radiological Health (HFZ-220), 1350 Piccard Dr. Rockville, MD 20850, FAX 
301-443-8818; or from http://www.fda.gov/opacom/morechoices/fdaforms/
cdrh.html on the Internet.

[65 FR 17136, Mar. 31, 2000]