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FDA publishes revisions to list of recognized standards.

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September 16, 2009 - U.S. FDA has issued new revisions to its list of accepted standards for use in premarket reviews of medical devices. Newly recognized standards include IEC 62366:2007, which helps manufacturers improve usability and safety of medical devices; ANSI/AAMI RD5:2003 (R2008) to ensure effective, safe performance of hemodialysis systems, devices, and related materials; and ASTM F2603-06, Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds.

Food and Drug Administration Publishes Revisions to List of Recognized Standards


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American National Standards Institute (ANSI)
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Press release date: September 10, 2009

The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in premarket reviews of medical devices.

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 organizations accredited by the American National Standards Institute (ANSI), 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: 022 contains both modified existing standards as well as new additions to the list of accepted standards. A total of 15 documents were added to the list in the fields of biocompatibility; in vitro diagnostics; materials; neurology; OB-GYN/gastroenterology; orthopedics; sterility; and tissue engineering.

A searchable database of the current list is maintained on the FDA website. Newly recognized standards include the following:

IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
This International Standard helps manufacturers improve the usability and safety of medical devices. Recognizing that all medical devices carry some level of inherent risk, the standard provides an engineering process for identifying, assessing and mitigating those risks during both intended and abnormal use.

IEC 62366:2007 was developed by IEC Subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice. The U.S. holds the secretariat for this subcommittee, which has been delegated to Medtronic, Inc. The Advanced Medical Technology Association (AdvaMed) acts as the United States National Committee (USNC)-approved U.S. Technical Advisory Group (TAG) Administrator, carrying U.S. positions forward to the committee.

ANSI/AAMI RD5:2003 (R2008), Hemodialysis Systems
The requirements established by this American National Standard (ANS) help to ensure the effective, safe performance of hemodialysis systems, devices, and related materials, including preparation and monitoring of dialysate, the fluid used in the dialysis process.

ANSI/AAMI RD5:2003 (R2008) was developed by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI organizational member and accredited standards developer.

ASTM F2603-06, Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
Tissue scaffolds, artificial medical implants that can support three-dimensional tissue formation, are key tools in reconstructive and regenerative medicine. This standard addresses the factors that need to be considered in obtaining and interpreting images of tissue scaffolds, including technique selection, instrument resolution and image quality, quantification, and sample preparation.

ASTM F2603-06 was developed by ASTM International, an ANSI member and audited designator.
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