FDA plans to use ISO 13485 for medical devices regulation - ISO.org

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Read the full news article: FDA plans to use ISO 13485 for medical devices regulation - ISO.org

"The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally. 

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States."

Learn more about the proposed rule:

• RIN: 0910-AH99 - Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
• Follow the status of the proposed rule on FDA.org (enter "0910-AH99" in the Search box)

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