Is the importer required to report adverse events to FDA and to the manufacturer?
A. Yes. Under the Medical Device Reporting regulations (21 CFR 803), importers must report to FDA and provide a copy of the report to the manufacturer if one of the importers marketed devices may have caused or contributed to a death or serious injury. 21 CFR 803.40. Such report must be submitted as soon as practicable, but not later than 30 days after the importer receives or otherwise becomes aware from any source of such information. Similarly, the importer must report to the manufacturer if one of the devices marketed by the importer has malfunctioned and such device or a similar device marketed by the importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 21 CFR 803.40. The report must be submitted on Medwatch Form 3500A, 21 CFR 803.40. You can find additional information on Medical Device Reporting at “Medical Device Reporting (MDR)”.
