CFR - Code of Federal Regulations Title 21

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2012]

[CITE: 21CFR803.11]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 803 -- MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec. 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms?

If you are a user facility, importer, or manufacturer, you must submit all reports of individual adverse events on FDA MEDWATCH Form 3500A or in an electronic equivalent as approved under 803.14. You may obtain this form and all other forms referenced in this section from any of the following:

(a) The Consolidated Forms and Publications Office, Beltsville Service Center, 6351 Ammendale Rd., Landover, MD 20705;

(b) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7240;

(c) Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.

(d) On the Internet athttp://www.fda.gov/medwatch/getforms.htm .

[72 FR 17399, Apr. 9, 2007, as amended at 75 FR 20914, Apr. 22, 2010]