FDAnews Device Daily Bulletin

FDA RELEASES MODIFICATIONS TO RECOGNIZED STANDARDS

April 11, 2006
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The FDA has announced the release of a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews.

The publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 014", will assist manufacturers who want to declare conformity with consensus standards to meet certain requirements for medical devices. The amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

For a list of the modifications, visit www.fda.gov/OHRMS/DOCKETS/98fr/E6-4695.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-4695.htm).