Does Medical Device training video falls under labeling requirement ?

[Ujjwal]

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]

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.

 

[akp060]

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

 

[Ujjwal]

Thank you @Orca1 @akp060 both for the reply, I will make sure the elements of the labeling requirements are address but would not be go full compliance mode on it.

 

[Ed Panek]

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.