federal_register: 2015-02801

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2015-02801 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 039 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. 2015-02-11 2015 2 https://www.federalregister.gov/documents/2015/02/11/2015-02801/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02801.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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