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The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.


Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
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Electronic Code of Federal Regulations

e-CFR data is current as of May 21, 2015

Title 21Chapter ISubchapter HPart 803Subpart A → §803.11


Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions


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

Link to an amendment published at 80 FR 10587, Feb. 27, 2015.

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 at http://www.fda.gov/medwatch/getforms.htm.

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


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