§ 804.25 - Reports by distributors.

(a)(1) A distributor, other than an importer, shall submit to FDA a report, and a copy of such report to the manufacturer, containing the information required by § 804.28 on FDA form 3500A as soon as practicable, but not later than 10 working days after the distributor 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from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that there is a probability that a device marketed by the distributor has caused or contributed to a death, serious illness, or serious injury.

(2) An importer shall submit to FDA a report, and a copy of such report to the manufacturer, containing the information required by § 804.28 on FDA form 3500A as soon as practicable, but not later than 10 working days after 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from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury.

(b)(1) A distributor, other than an importer, shall submit to the manufacturer a report containing information required by § 804.28 on FDA form 3500A, as soon as practicable, but not later than 10 working days after the distributor receives or otherwise becomes aware of information from any source, including user facilities, individuals, or through the distributor's own research, testing, evaluation, servicing, or maintenance of one of its devices, that one of the devices marketed by the distributor has malfunctioned and such information reasonably suggests that there is a probability that the device or any other device marketed by the distributor would cause a death, serious illness, or serious injury, if the malfunction were to recur.

(2) An importer shall submit to the manufacturer a report containing information required by § 804.28 on FDA form 3500A, as soon as practicable, but not later than 10 working days after the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or through the distributor's own research, testing, evaluation, servicing, or maintenance of one of its devices, that one of the devices marketed by the importer has malfunctioned and that 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.

(c) Distributors as defined in part 897 of this chapter shall submit medical device reports concerning cigarettes and smokeless tobacco under this part only for adverse events related to contamination.