FDA Publishes Amended Medical Device Premarket Review Standards
The Food and Drug Administration is announcing a publication containing modifications it 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,…
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Recognition List Number: 027" (Recognition List Number: 027), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.