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2012-03-16
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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028
Notices
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D09002ee1bdcbe5a4
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 a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
77 FR 15765
https://www.govinfo.gov/app/details/FR-2012-03-16/2012-6389
2012-6389
fr16mr12-93
4160-01-P
Docket No. FDA-2004-N-0451
https://www.govinfo.gov/app/details/FR-2012-03-16/2012-6389
https://www.govinfo.gov/content/pkg/FR-2012-03-16/html/2012-6389.htm
https://www.govinfo.gov/content/pkg/FR-2012-03-16/pdf/2012-6389.pdf
15 p.
15765
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77 FR 15765
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028; Federal Register Vol. 77, Issue
NOTICE
2012-6389
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2004-N-0451
4160-01-P
2012-6389
Notice.
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit either electronic or written comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993, 301-796-6574.
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List Number 028
,
standards@cdrh.fda.gov
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
http://www.fda.gov/MedicalDevices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm
Federal Register
Vol. 77, no. 52
Office of the Federal Register, National Archives and Records Administration
2012-03-16
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https://www.govinfo.gov/app/details/FR-2012-03-16
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https://www.govinfo.gov/content/pkg/FR-2012-03-16/xml/FR-2012-03-16.xml
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