Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.11: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.