10418. INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS

10418 INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS 10418.1 When reporting deaths or serious injuries, an importer shall submit a report to the Department, and a copy of this report to the manufacturer, as soon as practicable but no later than thirty (30) calendar days after the day that the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one (1) of the importer’s marketed devices may have caused or contributed to a death or serious injury. 10418.2 When reporting malfunctions, an importer shall submit a report to the manufacturer as soon as practicable but no later than thirty (30) calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through the importer’s own research, testing, evaluation, servicing, or maintenance of one of the importer’s devices, that reasonably suggests that one (1) of the 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. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10418