Does FDA allow e-labeling?

Rocke

Involved In Discussions
#1
I have been unable to find any information on FDA's website concerning this.
As a manufacturer of IVDs for professional use (lab assays), we are allowed to supply IFUs on a website in Europe. The user accesses the correct IFU via a key-code given on the label, which also contains basic information for identification and contact information to the manufacturer.

Does anybody know if FDA accepts this approach or if they will insist on having a printed IFU included in the packaging?

Best regards
Camilla
 
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SSchoepel

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#4
I'm going to ask my question as part of this thread since it's related. We are software-only. We are delivering the user manual electronically with the software product from a website.

According to the FDA we have to provide a printed user manual if the customer requests it/is unable to access the electronic version.

Am I correct in assuming that since a hard copy user manual is not our primary media, it is a "secondary" FDA requirement, and we have no other manufacturing since it's software-only, that I do not need to consider or include the production of hard copy user manuals as a manufactured item? (21 CFR 820.70h)

Regards,
S. Schoepel
 
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