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Regulatory Information
2019_register
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2019-10-24
article
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052
Notices
D09002ee1bdb6b644
D09002ee1bdb6b6ad
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 Agency) 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: 052'' (Recognition List Number: 052), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
84 FR 57034
https://www.govinfo.gov/app/details/FR-2019-10-24/2019-23198
2019-23198
fr24oc19-42
4164-01-P
Docket No. FDA-2004-N-0451
https://www.govinfo.gov/app/details/FR-2019-10-24/2019-23198
https://www.govinfo.gov/content/pkg/FR-2019-10-24/html/2019-23198.htm
https://www.govinfo.gov/content/pkg/FR-2019-10-24/pdf/2019-23198.pdf
8 p.
57034
57041
84 FR 57034
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052; Federal Register Vol. 84, Issue
NOTICE
2019-23198
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-10-24
Docket No. FDA-2004-N-0451
4164-01-P
2019-23198
Notice.
The Food and Drug Administration (FDA or Agency) 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: 052'' (Recognition List Number: 052), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable October 24, 2019.
Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, CDRHStandardsStaff@fda.hhs.gov.
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List Number: 052
,
CDRHStandardsStaff@fda.hhs.gov
http://www.regulations.gov
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/recognition-standard
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 206
Office of the Federal Register, National Archives and Records Administration
2019-10-24
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2019-10-24
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