(ANSI: New York) -- The U.S. Food and Drug Administration recently issued an updated list of consensus standards for use in evaluating medical devices before they are approved by the agency for market entry.

The Food and Drug Administration Modernization Act of 1997 authorized the FDA to recognize voluntary consensus standards developed in an open and transparent process, such as those developed by ANSI-accredited standards-developing organizations as well as the International Organization for Standardization and the International Electrotechnical Commission.

Modifications to the “List of Recognized Standards, Recognition List Number: 019” include nearly 100 changes to the FDA’s roster of accepted standards. In addition to the withdrawal and/or revision of previously accepted documents, the updated list adds 20 newly recognized standards. A searchable database of the current list—including nearly 150 U.S. national standards—is maintained on the FDA web site.

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