Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS Members,
I was wondering if FDA allows manufacturers to have "Electronic Package Inserts" for IVD kits available per shipment to customers, instead of having physical package inserts included with product kits.

Thank you in advance for your comments.

This message was posted by a user wishing to remain anonymous

Required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost.

https://www.govinfo.gov/content/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec352.htm

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/section-206-medical-device-user-fee-and-modernization-act-mdufma-new-section-502f-federal-food-drug

Original Message:
Sent: 06-Feb-2024 15:39
From: Anonymous Member
Subject: Electronic Package Inserts for US Market for IVD products

This message was posted by a user wishing to remain anonymous

Hello RAPS Members,
I was wondering if FDA allows manufacturers to have "Electronic Package Inserts" for IVD kits available per shipment to customers, instead of having physical package inserts included with product kits.

Thank you in advance for your comments.

Yes, the FDA does allow for electronic IVD  PIs. As the manufacturer, one must have a documented procedure for swiftly sending the paper IVD information upon request. 

There is one concern which is not all labs have use of the internet. Therefore this situation when the employer prevents use, it may behoove you to survey your current customer base. 

------------------------------
Carol Cooper RAC
Principal
CM Cooper & Associates
Libertyville IL
United States
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Original Message:
Sent: 06-Feb-2024 15:39
From: Anonymous Member
Subject: Electronic Package Inserts for US Market for IVD products

This message was posted by a user wishing to remain anonymous

Hello RAPS Members,
I was wondering if FDA allows manufacturers to have "Electronic Package Inserts" for IVD kits available per shipment to customers, instead of having physical package inserts included with product kits.

Thank you in advance for your comments.

This message was posted by a user wishing to remain anonymous

This is a conversation to have with your FDA reviewers because the advice posted by two others below did not apply in the case of the product I support. Our FDA reviewers of our IVD informed us last year that our IVD requires minimum physical labeling based on 21 CFR 809.10b.  Our FDA reviewers told us that their legal team said we need to add more content to our package insert to cover all the requirements of 809.10b, despite the package insert saying full labeling is available online and printed labeling provided if requested.  This was a shift in how we've labeled this product ever since it first entered the US market several years prior. Our labeling content essentially doubled because of this "shift" in interpretations by their legal team on what's required to meet 21 CFR 809.10b. 

Original Message:
Sent: 06-Feb-2024 15:39
From: Anonymous Member
Subject: Electronic Package Inserts for US Market for IVD products

This message was posted by a user wishing to remain anonymous

Hello RAPS Members,
I was wondering if FDA allows manufacturers to have "Electronic Package Inserts" for IVD kits available per shipment to customers, instead of having physical package inserts included with product kits.

Thank you in advance for your comments.

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 intended to be used by patients or for near-patient testing, FDA will - in our experience - require you to supply the IFU and other relevant labeling content in paper format.

Best regards,

Hans

------------------------------
Hans Strobel
www.dokspot.io
------------------------------

Original Message:
Sent: 06-Feb-2024 15:39
From: Anonymous Member
Subject: Electronic Package Inserts for US Market for IVD products

This message was posted by a user wishing to remain anonymous

Hello RAPS Members,
I was wondering if FDA allows manufacturers to have "Electronic Package Inserts" for IVD kits available per shipment to customers, instead of having physical package inserts included with product kits.

Thank you in advance for your comments.