Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 039

Streszczenie

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.