Source: https://www.law.cornell.edu/cfr/text/21/803.30?qt-cfr_tabs=0
Timestamp: 2015-03-03 19:34:37
Document Index: 631019736

Matched Legal Cases: ['§ 803', '§ 803', '§ 803', '§ 803', '§ 803', '§ 803', '§ 803', '§ 803']

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.
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.
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).
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).