[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.124]

[Page 136-137]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H--Humanitarian Use Devices
 
Sec. 814.124  Institutional Review Board requirements.

    (a) IRB approval. The HDE holder is responsible for ensuring that a 
HUD approved under this subpart is administered only in facilities 
having an Institutional Review Board (IRB) constituted and acting 
pursuant to part 56 of this chapter, 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

[[Page 137]]

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 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.
    (b) Withdrawal of IRB approval. A holder of an approved HDE shall 
notify FDA of any withdrawal of approval for the use of a HUD by a 
reviewing IRB within 5 working days after being notified of the 
withdrawal of approval.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]