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Quality Digest

FDA Compliance

FDA Issues a List of Standards for Medical Devices

Published: Tuesday, April 25, 2006 - 22:00

The U.S. Food and Drug Administration recently issued an updated list of agency-approved consensus standards for the evaluation of medical devices. "Modifications to the List of Recognized Standards, Recognition List Number: 014" includes more than 50 changes to the FDA’s roster of accepted standards. In addition to the withdrawal and/or revision of previously accepted standards, the updated list adds 22 newly recognized standards.

The standards on the list evaluate the safety and performance of an array of medical devices, ranging from medical face masks and examination gloves to radiography equipment and cardiovascular implants. Newly recognized standards include those that pertain to the sterilization of health care products, prosthesis knee-joint implant surgery, the effect of chemotherapy drugs on medical gloves and infant radiant warmer equipment.

A searchable database of the current list is maintained on the FDA’s Web site. For more information, visit www.ansi.org or www.fda.gov.


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