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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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 for medical devices. 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.

The following guidance document is applicable to all recognized standards:

  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

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