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HHS/FDA | RIN: 0910-AC25 | Publication ID: Spring 2011 |
Title: Medical Devices; Exception From General Requirements for Informed Consent | |
Abstract: This final rule will affirm 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: Final Rule Stage |
Major: No | Unfunded Mandates: No |
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 |
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Timetable:
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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 |