United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-08-18 article Notices D09002ee1c7fc935b D09002ee1c7fc93fc United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org 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: 029" (Recognition List Number: 029), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. 77 FR 50114 https://www.govinfo.gov/app/details/FR-2012-08-20/2012-20323 2012-20323 FR20AU12-87 4160-01-P Docket No. FDA-2004-N-0451 https://www.govinfo.gov/app/details/FR-2012-08-20/2012-20323 https://www.govinfo.gov/content/pkg/FR-2012-08-20/html/2012-20323.htm https://www.govinfo.gov/content/pkg/FR-2012-08-20/pdf/2012-20323.pdf 8 p. 50114 50121 77 FR 50114 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029; Federal Register Vol. 77, Issue NOTICE 2012-20323 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2004-N-0451 4160-01-P 2012-20323 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: 029" (Recognition List Number: 029), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Submit written or electronic 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. Modifications to the List of Recognized Standards , 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 Vol. 77, no. 161 Office of the Federal Register, National Archives and Records Administration 2012-08-20 continuing daily deposited born digital 391 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-08-20 P0b002ee18342a4e1 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR20AU12 https://www.govinfo.gov/app/details/FR-2012-08-20 https://www.govinfo.gov/content/pkg/FR-2012-08-20/pdf/FR-2012-08-20.pdf https://www.govinfo.gov/content/pkg/FR-2012-08-20/xml/FR-2012-08-20.xml fdlp 49991 50370 DGPO 2012-08-18 2024-06-03 FR-2012-08-20 machine generated eng FR FR-2012-08-20 77 161