CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 803—MEDICAL DEVICE REPORTING > SUBPART C—User Facility Reporting Requirements (§803.30 to §803.33) > 803.30—If I am a user facility, what reporting requirements apply to me?

803.30—If I am a user facility, what reporting requirements apply to me?

(a) You must submit reports to the manufacturer or to us, or both, as specified below:
(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 report information required by § 803.32 on FDA Form 3500A or an electronic equivalent approved under § 803.14.
(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 on FDA Form 3500A or an electronic equivalent approved under § 803.14.
(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.