[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.124]

[Page 150]
 
                        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 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]

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