Recognized Consensus Standards: Medical Devices

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.

Search Database Standards Search Assistance

This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco.

Links on this page:

Page Last Updated: 05/29/2024