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U.S. Department of Health and Human Services

Recognized Consensus Standards

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This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity. After FDA has decided to recognize a standard, we will update our online database to reflect the decision even before formal recognition of the standard occurs by publication in the Federal Register. Publications in the Federal Register to the lists of recognized consensus standards can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.

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Note: numbers only, e.g., 14971, 60601-1

Note: do not include standard designation number
      (e.g., 888.1111)  
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