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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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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.