Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does FDA allow eIFUs for IDE studies? The regulation is not explicit, I could infer this to assume it is permitted but wanted to check with the RAPs community who might have used eIFU for IDE devices. 

Section 352(f) of the Federal Food, Drug and Cosmetic Act states: Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.

Anon,

They can be yes, though highly depends on the device and the study being done, i.e. unknown device or technology or procedure.  As part of the IDE application, typically there would be a Q-Submission meeting where could confirm if an eIFU would be accepted for the study or not.  I have not experienced it myself as the devices all used a paper version, but FDA is fairly progressive, but again it depends on the device and any risk or perceived risk with an eIFU.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 01-May-2024 18:43
From: Anonymous Member
Subject: eIFU for IDE (FDA)

This message was posted by a user wishing to remain anonymous

Does FDA allow eIFUs for IDE studies? The regulation is not explicit, I could infer this to assume it is permitted but wanted to check with the RAPs community who might have used eIFU for IDE devices. 

Section 352(f) of the Federal Food, Drug and Cosmetic Act states: Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.

Dear fellow RAPS member

The basic question is what role the IFU plays in your IDE study design. Assuming that the IFU is relevant for the intended user, access to the IFU is mandatory, be it in paper or electronic. If the intended user is a healthcare professional you can provide the IFU in electronic format exclusively. The IDE device would have to be labeled for eIFU.

If the intended user of the device is a healthcare professional go for eIFU and use the IDE study to collect evidence that eIFU is safe and efficient for the intended user. 

Kind regards.

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Hans Strobel
www.dokspot.io
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Original Message:
Sent: 01-May-2024 18:43
From: Anonymous Member
Subject: eIFU for IDE (FDA)

This message was posted by a user wishing to remain anonymous

Does FDA allow eIFUs for IDE studies? The regulation is not explicit, I could infer this to assume it is permitted but wanted to check with the RAPs community who might have used eIFU for IDE devices. 

Section 352(f) of the Federal Food, Drug and Cosmetic Act states: Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.