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2019-08-29
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Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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D09002ee1bdb6ddeb
United States
Department of Health and Human Services
originator
org
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 or Agency) is announcing the availability of a final guidance entitled ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices--premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls--PMAs for Breakthrough Devices and PMAs for devices for small patient populations.
84 FR 45771
https://www.govinfo.gov/app/details/FR-2019-08-30/2019-18802
2019-18802
fr30au19-83
4164-01-P
Docket No. FDA-2018-D-3130
https://www.govinfo.gov/app/details/FR-2019-08-30/2019-18802
https://www.govinfo.gov/content/pkg/FR-2019-08-30/html/2019-18802.htm
https://www.govinfo.gov/content/pkg/FR-2019-08-30/pdf/2019-18802.pdf
3 p.
45771
45773
84 FR 45771
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-18802
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-3130
4164-01-P
2019-18802
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices--premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls--PMAs for Breakthrough Devices and PMAs for devices for small patient populations.
The announcement of the guidance is published in the Federal Register on August 30, 2019.
Sonja Fulmer, Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993- 0002, 240-402-5979.
Guidance:
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
,
CDRH-Guidance@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 169
Office of the Federal Register, National Archives and Records Administration
2019-08-30
continuing
daily
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256 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-08-30
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https://www.govinfo.gov/app/details/FR-2019-08-30
https://www.govinfo.gov/content/pkg/FR-2019-08-30/pdf/FR-2019-08-30.pdf
https://www.govinfo.gov/content/pkg/FR-2019-08-30/xml/FR-2019-08-30.xml
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FR-2019-08-30
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