Hello Anon
I haven't seen guidance on how long an investigation should take. There's a general expectation that it should be done promptly and expeditiously, and an understanding that more complex investigations are likely to take longer than simple ones.
The guidance is pretty clear about the reporting timeline. You have 30 days from whenever supplemental information becomes available, whether that is new facts or new evaluations of the available facts. And the "you" there means the manufacturer as a whole.
The company's designated complaint handling unit must have a system that facilitates internal communication. It sounds like you may have some disconnect there? It can be a challenge, when investigators are focused on the technical details of the investigation, not remembering to share interim findings proactively.
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Anne LeBlanc
United States
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Original Message:
Sent: 17-Nov-2022 20:33
From: Anonymous Member
Subject: FDA Medical Device 30 Day report Follow Up
This message was posted by a user wishing to remain anonymous
Is there a clear time frame for the follow-up for a 30-day reportable on a Medical Device to be reported to the FDA? I understand guidance states any time new information is received, a follow-up may be submitted within 30 days of receiving new details or information; however, it does not state anything in regards to how long you have after the investigation. If I am assuming, the investigation should be done in 30 days, but once that investigation is done, if it is not automatically sent over to the individual responsible for reporting the follow-up indicating the investigation results, it could go longer. Is there a documented expectation, or is it 30 days from the time the individual reporting receives that investigation from the quality investigator/team?
I would be grateful for any feedback.