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Regulatory Focus™ > News Articles > FDA Approves 32 New Medical Device Standards

FDA Approves 32 New Medical Device Standards

Posted 20 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced the adoption of a number of new international standards to guide the development and regulatory review of some medical devices.

The standards, collected within FDA's List of Recognized Standards, are used by FDA during the premarket review of some products and allow a company or product to claim conformity to the standards to satisfy certain components of the review process.

The FDA Amendments Act of 2007 allowed the agency to recognize international consensus standards if, like domestically developed standards, they are used to satisfy a component or need in the device premarket review process.

FDA's 17 August 2012 update to the List of Recognized Standards-its 29th since its inception-incorporates 32 new standards, with many of the standards hailing from international organizations.

Of the 32 new standards, the International Standards Organization (ISO) created 13, the American Society for Testing and Materials (ASTM) created 10, the International Electrotechnical Commission (IEC) created four, the American National Standards Institute (ANSI) created three and the Clinical and Laboratory Standards Institute (CLSI) created one.

The standards cover 10 areas: anesthesia, cardiovascular, general hospital/general plastic surgery, materials, GYN/gastroenterology, ophthalmic, orthopedic, radiology, software/informatics and sterility.

Read more:

FDA - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029


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