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

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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.

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.

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

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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