section_subject: "Generally, what are the reporting requirements that apply to me?"
cfr_reference: "21 CFR 803.10"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
(1)Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
(i)Submit reports of device-related deaths to us and to the manufacturer, if known, or
(ii)Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
(2)Submit annual reports (described in § 803.33) to us.
(b)If you are an importer, you must submit reports (described in subpart D of this part), as follows:
(1)Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
(i)Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
(ii)Submit reports of device-related malfunctions to the manufacturer.
(c)If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
(1)Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.
(2)Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
(i)A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
(ii)A reportable event for which we made a written request.
(3)Submit supplemental reports if you obtain information that you did not submit in an initial report.