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FDA's New MDR Regulations:What Manufacturers Need to Know

Edward M. Basile and Elizabeth A. Schmidtlein

BOX 3


MECHANICS OF MDR FILING

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

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