Hello Anon
Expected off-label use is challenging. FDA says
"If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)"
https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
Then it follows that updating the labeling to cover such uses may require a new 510k or PMA.
Occasional random off-label usage is one thing - you may simply document that in the risk files.
But where some type of off-label use is actually, consistently expected, the manufacturer has more responsibilities.
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Anne LeBlanc
United States
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Original Message:
Sent: 14-Mar-2023 14:02
From: Rajeswari Devanathan
Subject: How to document expected off label use of a class III device
Hi,
The documentation of expected off-label use of a Class III medical device to meet the requirements of the FDA involves several steps:
Conduct an assessment: The first step is to assess the potential off-label use of the device. This involves reviewing existing literature, clinical practice, and expert opinions to identify possible off-label uses.
Document the assessment: Document the assessment process and the conclusions drawn from it. The documentation should include a list of potential off-label uses, their risks, and benefits.
Obtain regulatory guidance: Consult with the FDA to determine the regulatory requirements for documenting the expected off-label use of the device. This may involve submitting a premarket approval application or seeking guidance from the FDA's Center for Devices and Radiological Health (CDRH).
Develop a labeling strategy: Develop a labeling strategy that clearly describes the intended use of the device and any known off-label uses. The labeling should also include information on the risks and benefits of the device, as well as any special precautions that should be taken when using the device for off-label purposes.
Maintain updated documentation: Keep the documentation up-to-date as new information becomes available, and continue to monitor the off-label use of the device to identify any potential risks or adverse events.
It is essential to ensure that any off-label use of a Class III medical device is based on sound clinical evidence and is in the best interest of the patient.
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 14-Mar-2023 12:43
From: Anonymous Member
Subject: How to document expected off label use of a class III device
This message was posted by a user wishing to remain anonymous
Hello everyone,
I am looking for guidance on, how to document expected off label use of a class III device. Any kind of guidance will be highly appreciated, thank you.