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2018-02-22
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Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability
Notices
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D09002ee1bdc2fb7a
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).'' The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor- investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time.
80 FR 34909
https://www.govinfo.gov/app/details/FR-2015-06-18/2015-14982
2015-14982
fr18jn15-70
4164-01-P
Docket No. FDA-2015-D-1777
https://www.govinfo.gov/app/details/FR-2015-06-18/2015-14982
https://www.govinfo.gov/content/pkg/FR-2015-06-18/html/2015-14982.htm
https://www.govinfo.gov/content/pkg/FR-2015-06-18/pdf/2015-14982.pdf
2 p.
34909
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80 FR 34909
Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-14982
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-1777
4164-01-P
2015-14982
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).'' The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor- investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2015.
Sugato De, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
Guidance:
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
,
CDRH-Guidance@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 117
Office of the Federal Register, National Archives and Records Administration
2015-06-18
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361 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-06-18
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https://www.govinfo.gov/app/details/FR-2015-06-18
https://www.govinfo.gov/content/pkg/FR-2015-06-18/pdf/FR-2015-06-18.pdf
https://www.govinfo.gov/content/pkg/FR-2015-06-18/xml/FR-2015-06-18.xml
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