COMPASSIONATE USE OF A DEVICE WITH AN IDE
The compassionate use provision can be used when the following conditions apply:
- You wish to use the unapproved device on a single patient;
- The patient has a serious disease or condition for which the device is intended to treat;
- The patient is unable to qualify for a clinical trial using the unapproved device; and,
- There is no comparable device or therapy.
The device may only be used during the clinical trial for which the device is being tested.
Physician Responsibilities for Compassionate Use
| 1. |
The Physician must request approval from the Medical Developer of the device for non-emergency use under the company's IND. If the Medical Developer declines permission to use the device, the Physician cannot move forward. |
| 2. |
The Developer is responsible for submitting the IDE supplement to the FDA requesting approval for a protocol deviation. FDA Concurrence must be obtained prior to compassionate use. |
| 3. |
The Physician should devise a schedule for patient monitoring that addresses the specific needs of the patient and detects any possible problems that may arise. |
| 4. |
Prior to treatment, Physician should obtain Concurrence from the IRB Chair. |
| 5. |
Treating Physician should request an assessment by an Independent Physician not participating in the treatment. |
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6. |
Physician must obtain informed consent from the individual receiving the device. The Non-Emergency Use of a Test Article Consent Form can be used if one is not provided by sponsor. |
|
7. |
Physician can proceed with treatment. |
| 8. |
If problems arise during and after use of the device, report problems to the LSUHSC IRB and the Medical Developer. |
| 9. |
Within 5 business days of use, the Physician should follow-up with the IRB by submitting the After Use section of the EATA application in Kuali. |
| 10. |
Physician must write a summary of the use of the device and provide it to the Medical Developer. |
FDA Forms, Templates, & Helpful Links
