Table 3.

Elements in the IDE Supplement for Expanded Use of an Investigational Device

•Description of the patient’s condition and circumstances necessitating treatment

•Discussion of why alternative therapies are unsatisfactory and why probable risk of use of the device is no greater than probable risk of the disease or condition

•Identification of any deviations from the approved investigational (clinical) protocol that are needed for the patient

• List of patient protections measures that will be followed ○ Draft of the informed consent document ○ Clearance by the institution as specified in their policies ○ Concurrence of the IRB chairperson∗ ○ Independent assessment by an uninvolved physician ○ Authorization from the device manufacturer

Abbreviations as in Table 2.

^∗In some cases, the IRB will not give final approval until FDA approval is obtained. In that case, the request should indicate that IRB approval will be obtained before use of the device. Proof of approval by the IRB chairperson must be submitted with the follow-up report after the patient is treated.