U.S. FDA Modifies List of Recognized Medical Device Standards
January 14, 2008 // Published as a news service by IHS
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The U.S. Food and Drug Administration (FDA) updated the list of consensus standards for use in evaluating medical devices before they are approved by the agency for market entry.
The FDA Modernization Act of 1997 authorized the FDA to recognize voluntary consensus standards developed in an open and transparent process, such as those developed by American National Standards Institute (ANSI)-accredited standards developing organizations (SDOs), as well as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
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 American national standards, is maintained on the FDA web site.
The standards identified in Recognition List Number: 019 evaluate the safety and performance of an array of medical devices, ranging from anesthetic equipment and surgical drapes to microlens arrays and contact lenses. Newly recognized standards include:
For more information, or to see the complete list of modified and additional standards, see the Federal Register notice at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-24580.htm.
Source: American National Standards Institute (ANSI).