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Regulatory Focus™ > News Articles > Dozens of Medical Device Standards Adopted, Re-Affirmed by FDA

Dozens of Medical Device Standards Adopted, Re-Affirmed by FDA

Posted 15 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new Federal Register notice indicating the modification of 116 medical device standards recognized by the agency, as well as 38 new device standards now recognized.

The oft-updated List of Recognized Standards is generally updated anywhere between one and three times per year, and was last updated in August 2012 and before that in March 2012. It was created under the FDA Modernization Act of 1997, which gave the agency the authority to recognize the work of outside organizations.

To that effect, a huge number of organizations are recognized, including the US Pharmacopoeia (USP), the International Standards Organization (ISO), the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI), the International Electrotechnical Commission (IEC), the American Dental Association (ADA), the American Society for Testing and Materials (ASTM), the Clinical and Laboratory Standards Institute (CLSI) and the Association of Official Analytical Chemists (AOAC).

The new standards cover a number of areas, including cardiovascular devices, dental devices, general medical equipment, needles, in vitro diagnostics, the quality of certain materials, gastroenterology devices, ophthalmic devices, orthopedic devices, radiological equipment, software and the sterility of devices/device packaging.

Changes to the 116 existing standards included either withdrawing the standard entirely, replacing the standard with a newer version, extending recognition for an addition amount of time, updating the title of the standard, reaffirming the standard or making smaller changes such as updating the contact information on a particular document.

All standards may be found on the Center for Devices and Radiological Health's (CDRH) standards web page. Comments on the new standards may be submitted to FDA at any time, and the public is also allowed to suggest any standards for adoption at any time they so choose.


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