You are correct the premise of "becomes aware" applies to any type of interaction with a customer or patient, i.e. if a Sales rep is in a hospital where someone tells them about a problem they are having with a device. The Sales rep then becomes aware. This would be the same for social media posts or information seen or reviewed by the company. Of course this opens up a large can of worms related to social media and what would be considered feedback or a complaint. Then is it an actual valid complaint or someone just venting on a public forum. I have worked with a couple companies to address posting on social media, and you should establish and implement a procedure for handling this type of data source.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Nov-2019 10:10
From: Anonymous Member
Subject: Handling Complaints from Facebook, Social Media
This message was posted by a user wishing to remain anonymous
Has anyone seen updated guidance from FDA on how to handle complaints obtained from its Facebook site and other social media? I believe the 'becomes aware' applies as well to FB, but after following its procedures for analyzing it like any other complaint of which it has been made aware, must a manufacturer respond to every post? Should a firm respond with a request to report the complaint through more formal channels, including their physician?
Thanks in advance.