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2015-04-11
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Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
D09002ee1c1774a85
D09002ee1c1774b00
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process.
80 FR 19672
https://www.govinfo.gov/app/details/FR-2015-04-13/2015-08363
2015-08363
fr13ap15-75
4164-01-P
Docket No. FDA-2014-D-0090
https://www.govinfo.gov/app/details/FR-2015-04-13/2015-08363
https://www.govinfo.gov/content/pkg/FR-2015-04-13/html/2015-08363.htm
https://www.govinfo.gov/content/pkg/FR-2015-04-13/pdf/2015-08363.pdf
2 p.
19672
19673
80 FR 19672
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-08363
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-0090
4164-01-P
2015-08363
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301- 796-5178; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002.
Guidance for Industry and Staff:
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
,
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. 70
Office of the Federal Register, National Archives and Records Administration
2015-04-13
continuing
daily
deposited
born digital
367 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-04-13
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2015-04-13
https://www.govinfo.gov/content/pkg/FR-2015-04-13/pdf/FR-2015-04-13.pdf
https://www.govinfo.gov/content/pkg/FR-2015-04-13/xml/FR-2015-04-13.xml
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2015-04-11
2023-10-12
FR-2015-04-13
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FR-2015-04-13
80
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