Good day Tracy,
There is no specific scenario which is defined when information should be updated related to a Medical Device Report (MDR) under the US FDA, assuming as you mention 21 CFR 803. When providing supplemental information in the time frame is when a determination has been made about the product failure which allows additional information to be provided. In your scenario where a different type of malfunction occurred, it really depends if this was related to the original malfunction or not. Or in what way the two issues may be related to each other. Either of a) or b) could be done depending on the relationship of the malfunction and if any conclusion has been made. While the information you provided is helpful, much more detail would be needed to provide a succinct answer because there can be many circumstances which may have to be considered. Personally, when updating information for an adverse event report to the US FDA, be timely as possible, update information on a routine basis, and conclude the investigation in a timely manner. The timeframes they put from the regulation is to ensure companies are responding and updating information in a timely manner rather than just reporting something and then maybe updating months later.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Sep-2023 22:37
From: tracy hanly
Subject: Reporting New Information for Complaints
Hello,
I have a query regarding how the following situation is handled with respect to new information received during the lifecycle of a complaint investigation.
Thank you for your review and input. Our facility is trying to be more efficient with regards to the volume of reports generated and communications without impacting on reporting requirements.
The requirements state :
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).
Scenario: The facility completes and submits an initial report based on a malfunction for difficulty in the operation of the device. When the device is returned and evaluated a different type of malfunction is identified. It is unknown at this point whether the device was broken at the point of use and contributed to the difficulty in operating the device or if it broke during transportation on the return of the device. If it broke at the point of use then the malfunction reported in the supplemental report would be changed. If the investigation concluded the device broke on return from the facility then the original malfunction would remain the same. Which scenario would your facility perform?
a) send in a supplemental or follow-up report with this new information and conclude the investigation is still ongoing
b) do not send in a supplemental or follow-up until the investigation has been concluded but acknowledge within the reporting assessment that this information has been identified but not reported at this time as the investigation is outstanding.
c) other.. please explain
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tracy hanly
Limerick Limerick
Ireland
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