If an emergency arises where an unapproved medical device may offer the only possible life-saving alternative, but an Investigational Device Exemption (IDE) for the device does not exist, or the proposed use is not approved under an existing IDE, a physician may use the device if each of the following conditions exist: 1) the patient is in a life-threatening condition requiring immediate treatment; 2) no generally acceptable alternative is available; and 3) there is no time to use existing procedures to get FDA approval for the use. Approval should be sought from the CPHS Chairperson as described below for the compassionate use of an unapproved drug:

When a physician wishes to use an investigational device for treatment of an individual patient for a single use or a single course of treatment, and the use is not covered by an existing CPHS approved protocol, call the CPHS office (713-500-7942) with your request and justification. The Chairperson will advise if the justification for such use is sufficient for approval. A written memo outlining the situation must be received by the CPHS within 5 days of the telephone approval.

The manufacturer of the device will usually add the physician as a clinical investigator on its INE. If the sponsor will not, or if there is no commercial sponsor, the physician can file an individual INE directly with the FDA (phone numbers: 301-827-0531/301-594-2000/after hours 202-857-8400). An INE number will usually be given over the phone which permits the sponsor to ship the device. An appropriate informed consent form must be constructed for use of the device and informed consent obtained from the patient or responsible relative prior to using the device.

When the situation is life threatening and there is no time for CPHS approval, the physician may use the device without such approval. A second non-involved physician should concur in the use of the investigational article. The CPHS MUST be subsequently notified.

If the physician/clinical investigator anticipates that there will be more such use of the same device, for the same patient or any additional patients, review and approval of a protocol at a convened CPHS meeting is necessary.

The Center for Devices and Radiological Health (phone numbers: 301-594-1190 / after hours 202-857-8400) must be notified immediately after shipment of the device from the manufacturer is made. The physician must justify in writing to the FDA that an emergency actually existed.