§ 804.32 - Supplemental information.

(a) Only one MDR is required under this part if the distributor becomes aware, from more than one source, of information concerning the same patient and the same event.

(b) An MDR that would otherwise be required under this section is not required by the distributor if:

(1) The distributor determines that the information received is erroneous in that a death, serious injury, serious illness, or the malfunction did not occur; or

(2) The distributor determines that the information received is erroneous in that the device that is the subject of the information was distributed by another distributor. A distributor shall forward to FDA any report that is erroneously sent to the distributor, with a cover letter explaining that the product in question is not distributed by that firm.

(c) A report or information submitted by a distributor under this part (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, the establishment submitting the report, or employees thereof, caused or contributed to a death, serious injury, serious illness, or malfunction. A distributor need not admit, and may deny, that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a death or serious injury, serious illness, or malfunction.