Hi anon
I've limited, but some, experience of video IFUs for medical devices. I agree that they should be considered as part of the information for use, and thus all of the requirements, inputs and control measures for information for use should be considered and applied where applicable. Consider how the video of the content is to be approved internally; ensure that it is consistent with all other accompanying documentation and that there are no conflicts in directions for use, contraindications or warnings/precautions. Even simple things like having a device not indicated for paediatrics but then having pictures of children in the marketing brochures should be checked because of the implied instruction/direction for users. Consider them similar to an eIFU etc. in terms of 'document' control, and ensure that QMS processes can accommodate the development, release and change management for the media files. And definitely, maybe even more so than for written instructions, perform usability evaluations on the usability and effectiveness (as a risk control) of the media and any out software interface or platform(s) used to view the videos.
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Ed Ball
Manager, Intelligence & Innovation
United Kingdom
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Original Message:
Sent: 07-Nov-2023 11:22
From: Anonymous Member
Subject: Video IFU
This message was posted by a user wishing to remain anonymous
I'm trying to find FDA guidance on video IFU and marketing material for medical devices. I found a lot on drugs but not so much out there on medical devices. My understanding thus far is that a video IFU for patient which is a medical device would be considered labeling and would need approval by FDA. Is this not correct? Any information from those who have dealt a lot with videos for medical devices that go out to patients or put on websites would be welcomed knowledge! Thank you