Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 032

摘要

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 interoperability of medical devices. This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 032" (Recognition List Number: 032), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.