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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2016]
[CITE: 21CFR803.11]
See Related Information on What form should I use to submit reports of individual adverse events and where do I obtain these forms? in CDRH databases



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?

(a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with 803.12(a) and 803.20, unless granted an exemption under 803.19.

(b) Importer reports submitted to device manufacturers may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information.

(c) If you are a user facility, you must submit reports of individual adverse events in accordance with 803.12(b) and 803.20.

(d) Form FDA 3500A is available on the Internet at http://www.fda.gov/medwatch/getforms.htm or from Division of International and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: DICE@fda.hhs.gov, FAX: 301-847-8149, or telephone: 800-638-2041.

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