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Compliance In Focus
Posted by Jaime Wynbrandt on Wed, Mar 26, 2014

Compassionate Use in Unapproved Medical Devices

Compassionate Use in Unapproved Medical DevicesWhen and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.

What is compassionate use?

  • It is the use of an unapproved device in a single patient or small group.
  • It is not considered research; if there is a clinical study using the device, the patient would not meet inclusion criteria.
  • The patient’s condition must be serious and there must be no other alternative treatment.

What are the physician’s responsibilities?

  • The physician would first need to seek approval from the Sponsor and then from the institution’s IRB.
    • If the Sponsor or IRB disagrees with the use, the physician can not use the device.
  • The physician needs to provide any possible problems and a plan to monitor the patient to the Sponsor.
  • Prior to use, the Sponsor needs to submit an IDE supplement to the FDA requesting approval for a protocol deviation.
  • If approval is given from the FDA, the patient would need to sign an informed consent document agreeing to the compassionate use of the device.
  • After use of the device, the physician would need to report any issues to the IRB and Sponsor.

The IRB also has responsibilities after approving the compassionate use of a device. The IRB needs to retain documentation of IRB and FDA approval. The IRB also needs to review submission of any issues reported by the physician.

Have you worked with a site that used a device in a compassionate situation before?  How did you ensure the proper actions were carried out?  Please share your experiences with us.

Photo Credit: Leonard John Matthews

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Topics: Medical Devices, Compassionate Use, FDA


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