Edward M. Basile and Elizabeth A. Schmidtlein

Where to Obtain Forms

Center for Devices and Radiological Health Internet Home Page

Division of Small Manufacturers Assistance

Office of Health and Industry Programs

Center for Devices and Radiological Health

1350 Piccard Dr. (HFZ-220)

Rockville, MD 20850

301/827-0111 (Fax on Demand)

Food and Drug Administration

MedWatch (HF-2)

5600 Fishers Ln., Rm. 9-57

Rockville, MD 20850

301/443-0117

(Form 3500A only)

Where to Submit Reports

All written reports (5-day, 30-day, and baseline reports) and information:

Food and Drug Administration

Center for Devices and Radiological Health

Medical Device Reporting

P. O. Box 3002

Rockville, MD 20847-3002

Public health emergencies:

FDA Emergency Operations Branch

301/443-1240 and follow with a fax to 301/443-3757

Voluntary telephone reports:

MedWatch Hotline

800/FDA-1088