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HHS/FDA RIN: 0910-AC25 Publication ID: Fall 2011 
Title: Medical Devices; Exception From General Requirements for Informed Consent 
Abstract: This rule affirmed the interim final rule's exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. Informed consent will be required unless the clinical investigator determines in writing that: 1) There exists a life-threatening situation involving the human subject of such testing which necessitates the use of the investigational device; 2) it is not feasible to obtain informed consent from the subject; and 3) there is not sufficient time to obtain such consent from his or her representative. Further, a licensed physician uninvolved in the testing must agree in writing with this three-part determination before the product is used unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to get such concurrence. This final rule adds a requirement that the investigator submit this required documentation to FDA, in addition to submitting the documentation to the Institutional Review Board (IRB). 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 50.23   
Legal Authority: 21 USC 321    21 USC 343    21 USC 346 to 346a    21 USC 348    21 USC 350a    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c to 360f    21 USC 360h to 360j    21 USC 371    21 USC 379e    21 USC 381    42 USC 216    42 USC 241    42 USC 262    42 USC 263b to 263n   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  06/07/2006  71 FR 32827   
Interim Final Rule Comment Period End  08/07/2006    
Final Action  06/24/2011  76 FR 36989   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Claudia M. Gaffey
Medical Officer
Department of Health and Human Services
Food and Drug Administration
Room 314/HFZ-314, Center for Devices and Radiological Health, WO66, Room 5516, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6196
Fax:301 847-8144
Email: claudia.gaffey@fda.hhs.gov