Hi Rashmi,
5-day reports are required under certain circumstances and are not specific to certain device types.
Please refer to the following references from the FDA website for information on when a 5-day report is required:
21CFR803.53
PART 803 -- MEDICAL DEVICE REPORTING
Subpart E--Manufacturer Reporting Requirements
| Sec. 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report? |
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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:
(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis or
(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.
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Guidance: Medical Device Reporting for Manufacturers
2.20 What are 5-day reports?
A "5-day report" (or five-day report) is a report that must be submitted to us within five work days after the day you become aware of an MDR reportable event:
• That necessitates remedial action to prevent an unreasonable risk of substantial harm to public health (remedial action is described in section 2.21 of this guidance); or
• For which we have made a written request for the submission of 5-day reports [21 CFR 803.10(c), 803.20, 803.53].
We consider the 5-day time frame for a report of an event requiring remedial action, as in the first bullet above, to begin the day after an employee with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, "becomes aware" of the event [21 CFR 803.3]. We do not expect employees such as non-technical staff to recognize that an adverse event(s) requires remedial action to prevent a risk of substantial harm to the public.11
However, when you receive a written request for 5-day reports from us, you must submit the applicable reports within 5 work days after the day any employee becomes aware of the event [21 CFR 803.10(c), 803.20, 803.53].
Hope this helps,
Liz
------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States
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Original Message:
Sent: 14-Jan-2018 05:54
From: Rashmi Pillay
Subject: 3500A - FDA 5 day reporting
Hi,
A general query – which type of devices and which events ( pl. give me examples) require a 5 day, 3500 A reporting to the FDA.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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