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Dear fellow RAPS Member For the US you can provide the IFU in electronic format exclusively if the device is intended to be used by professionals only and if you indicate how the device user can obtain a paper copy of the IFU. There needs to be an indication on the device labeling on how to access ...

Thank you for your feedback, glad the advice provided helpful. Kind regards,Hans

Hello Anon The key question is: Who is your customer? Or in other words: Who is the intended user? If the intended user is a professional, FDA will ask for a validated software and process (e.g. to supply paper IFU on request), but will not object to a electronic package insert. If the device is ...

Hello Kevin See attached. Kind regards Hans __________________ Hans Strobel www.dokspot.com ------------------------------ Hans Strobel www.dokspot.io ------------------------------