Providing Instructions for Use (IFU) vs. 'Help' pages

tebusse

Involved In Discussions
#1
Hello everyone!

I have a question pertaining to the Instructions for Use for a device compared to electronic 'help' pages/video tutorials.

The product my company manufactures is a PACS software application. I'm currently in the process of writing the Instructions for Use Manuals. However, my superiors have informed me that the IFU won't be posted online for our customers (available in paper by request only). Instead, the software currently has eletronic 'help' pages and video tutorials. The 'help' page correlates with whatever you're viewing on the screen - not a searchable tool.

Is this acceptable to meet FDA and EU (MDD 93/47/EEC) regulations? I thought the entire IFU manual had to be provided.

Please note, the IFU and 'help' pages do not correlate.

Any assistance would be greatly appreciated.

Regards, Tonia
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello everyone!

I have a question pertaining to the Instructions for Use for a device compared to electronic 'help' pages/video tutorials.

The product my company manufactures is a PACS software application. I'm currently in the process of writing the Instructions for Use Manuals. However, my superiors have informed me that the IFU won't be posted online for our customers (available in paper by request only). Instead, the software currently has eletronic 'help' pages and video tutorials. The 'help' page correlates with whatever you're viewing on the screen - not a searchable tool.

Is this acceptable to meet FDA and EU (MDD 93/47/EEC) regulations? I thought the entire IFU manual had to be provided.

Please note, the IFU and 'help' pages do not correlate.

Any assistance would be greatly appreciated.

Regards, Tonia
No, it's not acceptable. The IFU must be provided to the end-user by default. Providing it by electronic means carries additional requirements over a paper version.

Further, many regulatory obligations depend on what the IFU instructs or doesn't instruct, sometimes even by way of implication. It's a pivotal document that every user should have direct and easy access to.

Cheers,
Ronen.
 

tebusse

Involved In Discussions
#3
Ronen E,

Thank you for your response.

Are you able to provide any information regarding the documents discussing the additional requirements for electronic IFU?

Regards, Tonia
 

Ronen E

Problem Solver
Staff member
Moderator
#4
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