Electronic IFU - new project, need input

QIE

Registered
I have just been given a project to investigate/implement electronic IFU. Does the FDA accept eIFU for med devices? I see that the EU Commission Regulation No 207/2012 lists 5 types of medical devices it applies to, but does that mean that other categories of med devs CANNOT use eIFU or does it mean that they don't have to comply with all the requirements in the regulation? What about other countries? Any guidance would be appreciated.
 

duinyk

Involved In Discussions
I have the same question. As my device doesn't appear in the category of devices which require eIFUs but my company is considering it.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Bumping this thread to ask

Has anyone been audited by FDA and had their eIFU reviewed? Was there any feedback? Is an eIFU accepted without the use of a hardcopy shipped with the product?
 

ga2qa23

Involved In Discussions
eIFUs are easy content-wise, the most common issue is that the writer will put a too-small image that is impossible to print/read without zooming in on a computer screen without realizing it. But the biggest problem is often with the real-life logistics and accessibility of the eIFU. eIFU is accepted as long as the end user has clear & adequate means to be aware of its existence and how to access it. For example, you can include a single piece of paper with a QR Code to access the eIFU, or you can slap a sticker label with the QR Code on the outer package of your product.

Just be aware that your QR Code and the associated URL may need special configurations for the following...
  • Having multiple eIFUs available for download from a single URL.
  • Different languages of the eIFU
  • Different versions of the eIFU over time, versus only being allowed to access the most current version.
  • How will you ensure that the associated URL will be maintained? Will you own the website?
  • Making sure that no login credentials are needed to access the eIFU (some people make this mistake by having the URL navigate to a DropBox file but the DropBox itself is restricted the company employees only).
  • How you are controlling the QR Code itself through change control. Will you keep the QR Code controlled as part of the distribution paper sheet, packaging exterior, or a sticker label? Or will you keep the QR Code as its own controlled entity?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator

This is the FDA feedback on this exact question:


Dear Ed:

Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) [email protected] e-mail account.

Under the Medical Device Technical Corrections Act (MDTCA), electronic labeling alone may be used for:
· Prescription (Rx) medical devices that are only used by a healthcare professional;
· In vitro diagnostic devices used by a health care professional, regardless of the setting in which the device is used; and
· In vitro diagnostic devices used in blood establishments.
The MDTCA is at Summary of the Medical Devices Technical Corrections Act (MDTCA).

However, devices used by non-healthcare professionals require hard copy labeling. Please note that your company can use electronic IFU in addition to the required paper IFU for all situations not listed in the bullet points above.


Medical devices must be labeled in accordance with the requirements in 21 CFR 801. In vitro diagnostic (IVD) devices must also comply with the additional labeling regulations in 21 CFR 809.10. Additional labeling information is in the following documents:

Device Labeling Guidance #G91-1 (Blue Book Memo)
Device Labeling Guidance #G91-1 (Blue Book Memo)

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)

In Vitro Diagnostic Device Labeling Requirements
In Vitro Diagnostic Device Labeling Requirements

Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
Guidance on Medical Device Patient Labeling

Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices
Labeling Requirements for OTC Medical Devices

Labeling Requirements – Misbranding
Labeling requirements regarding misbranding

Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Guidance for Industry
Med. Product Communications Consistent With FDA-Required Labeling, QA


If you have general medical device regulatory questions, please email them to [email protected]. Additionally, please feel free to refer to DICE’s educational resources Device Advice (Device Advice) and CDRH Learn (CDRH Learn).

Best regards,

Industry Team
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify DICE by email at:[email protected] immediately.

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:

CDRH Customer Satisfaction Survey
 
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