(a) You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows:

(1) Reports of death. You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by §803.32. Reports sent to the Agency must be submitted in accordance with the requirements of §803.12(b).

(2) Reports of serious injury. You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by §803.32. Reports sent to the Agency must be submitted in accordance with the requirements of §803.12 (b).

(b) What information does FDA consider “reasonably known” to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.