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U.S. Department of Health and Human Services

Recognized Consensus Standards

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The CDRH Standards Program:

  • Created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards.
  • Modifications to the list of recognized consensus standards: Publications in the Federal Register to the list of recognized consensus standards can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
  • Please note that changes to the recognized consensus standards database are updated the following Monday.
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