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 2015_register executive 2015-02-10 article Notices D09002ee1c7f7f244 D09002ee1c7f7f2cb 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"). Specifically, this publication announces the addition of a list of recognized standards that are relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 039" ("Recognition List Number: 039"), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. 80 FR 7617 https://www.govinfo.gov/app/details/FR-2015-02-11/2015-02801 2015-02801 fr11fe15-71 4164-01-P Docket No. FDA-2004-N-0451 https://www.govinfo.gov/app/details/FR-2015-02-11/2015-02801 https://www.govinfo.gov/content/pkg/FR-2015-02-11/html/2015-02801.htm https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02801.pdf 3 p. 7617 7619 80 FR 7617 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 039; Federal Register Vol. 80, Issue NOTICE 2015-02801 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2004-N-0451 4164-01-P 2015-02801 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"). Specifically, this publication announces the addition of a list of recognized standards that are relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 039" ("Recognition List Number: 039"), 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 VI 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. 3632, Silver Spring, MD 20993, 301-796- 6287, standards@cdrh.fda.gov. 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 http://www.regulations.gov Vol. 80, no. 28 Office of the Federal Register, National Archives and Records Administration 2015-02-11 continuing daily deposited born digital 273 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-02-11 P0b002ee18b03d3b2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11fe15 https://www.govinfo.gov/app/details/FR-2015-02-11 https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/FR-2015-02-11.pdf https://www.govinfo.gov/content/pkg/FR-2015-02-11/xml/FR-2015-02-11.xml fdlp 7533 7796 DGPO 2015-02-10 2024-06-02 FR-2015-02-11 machine generated eng FR FR-2015-02-11 80 28