Does Medical Device training video falls under labeling requirement ?

U

Ujjwal

Registered
Hi All,

I am trying to understand if an investigation medical device training video, which is used as a refresher training aid, need to comply with any Labeling requirement or any other standard or not.
 
Orca1

Orca1

Involved In Discussions
It appears that a medical device training video may fall under labeling requirements if it contains information necessary for the safe and effective use of the device.
 
A

akp060

Involved In Discussions
It need not comply but should be part of your CIP/ investigation records (every time its used). Do not use it for any other purposes or for training anyone else, like patients/users and that should be fine
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
FDA could ask "Did you create and publish this video on product release?" if yes, ok. If no...have a good reason why it's not a safety issue.
 
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