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2015-12-29
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Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development
Notices
D09002ee18e373096
D09002ee18e373615
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 or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.
80 FR 81335
https://www.govinfo.gov/app/details/FR-2015-12-29/2015-32726
2015-32726
fr29de15-72
4164-01-P
Docket No. FDA-2012-N-1021
https://www.govinfo.gov/app/details/FR-2015-12-29/2015-32726
https://www.govinfo.gov/content/pkg/FR-2015-12-29/html/2015-32726.htm
https://www.govinfo.gov/content/pkg/FR-2015-12-29/pdf/2015-32726.pdf
5 p.
81335
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80 FR 81335
Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development; Federal Register Vol. 80, Issue
NOTICE
2015-32726
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-N-1021
4164-01-P
2015-32726
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.
Although you can comment on any guidance at any time, submit either electronic or written comments by February 29, 2016.
Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
Medical Device User Fee and Modernization Act:
Web Site Location of Fiscal Year 2016 Proposed Guidance Development
,
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm289534.htm
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm308079.htm
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm382508.htm
http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm394821.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm433165.pdf
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm470201.pdf
http://www.regulations.gov
Federal Register
Vol. 80, no. 249
Office of the Federal Register, National Archives and Records Administration
2015-12-29
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2015-12-29
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https://www.govinfo.gov/app/details/FR-2015-12-29
https://www.govinfo.gov/content/pkg/FR-2015-12-29/pdf/FR-2015-12-29.pdf
https://www.govinfo.gov/content/pkg/FR-2015-12-29/xml/FR-2015-12-29.xml
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