FDA updates the list of recognized consensus standards

The FDA published an updated list of consensus standards on Tuesday September 8, 2009. You may view it at http://edocket.access.gpo.gov/2009/pdf/E9-21609.pdf

The summary of the announcement says, “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). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 022’’ (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”