§803.12. How do I submit initial and supplemental or followup reports? — Inbound Citations

(b) If you are a manufacturer, importer, or user facility, you may request an exemption or variance from any or all of the reporting requirements in this part, including the requirements of § 803.12. You must submit the request to the Center for Devices and Radiological Health (CDRH) in writing at [email protected]. Your request must include information necessary to identify you and the device; a complete statement of the request for exemption, variance, or alternative reporting; and an explanation why your request is justified. If you are requesting an exemption from the requirement to submit reports to FDA in electronic format under § 803.12(a), your request should indicate for how long you will require this exemption.

(2) You must submit the postmarketing safety reports identified in § 4.102(c)(2)(ii) and (c)(3)(ii) in accordance with § 803.12(a) of this chapter if your combination product received marketing authorization under a device application.

(a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with § 803.12(a) and § 803.20, unless granted an exemption under § 803.19.

(b) If you are a manufacturer, importer, or user facility, you may request an exemption or variance from any or all of the reporting requirements in this part, including the requirements of § 803.12. You must submit the request to the Center for Devices and Radiological Health (CDRH) in writing at [email protected]. Your request must include information necessary to identify you and the device; a complete statement of the request for exemption, variance, or alternative reporting; and an explanation why your request is justified. If you are requesting an exemption from the requirement to submit reports to FDA in electronic format under § 803.12(a), your request should indicate for how long you will require this exemption.

(a) You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or otherwise become 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from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. You must submit the information required by § 803.42. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(a).

(a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market:

(1) May have caused or contributed to a death or serious injury or

(2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.

You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that:

If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this information. You must submit the supplemental or followup report in accordance with the requirements of § 803.12(a). On a supplemental or followup report, you must:

(c) If you are a user facility, you must submit reports of individual adverse events in accordance with § 803.12(b) and § 803.20.

(1) 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).