D.C. Mun. Regs. tit. 22, r. 22-B10631
The HDE holder is responsible for ensuring that a HUD approved under this section is administered only in facilities having an IRB constituted and acting pursuant to these regulations, including continuing review of use of the device. In addition, a HUD may be administered only if such use has been approved by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use and to which the local IRB has deferred in a letter to the HDE holder, signed by the IRB chair or an authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use. In such an emergency situation, the physician shall, within five (5) days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.
A holder of an approved HDE shall notify the Department of any withdrawal of approval for the use of a HUD by a reviewing IRB within five (5) working days after being notified of the withdrawal of approval.
D.C. Mun. Regs. tit. 22, r. 22-B10631