CFR

803.40—If I am an importer, what kinds of individual adverse event reports must I submit, when must I submit them, and to whom must I submit them?

(a) Reports of deaths or serious injuries. You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. This report must contain the information required by § 803.42, on FDA form 3500A or an electronic equivalent approved under § 803.14.

(b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that reasonably suggests that one of your devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. This report must contain information required by § 803.42, on FDA form 3500A or an electronic equivalent approved under § 803.14.

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