What is an FDA-recognized consensus standard?
It is a voluntary consensus standard for which FDA publishes a recognition decision. The detail record identifies the recognized version, extent and supporting information.
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FDA Recognized Consensus Standards Finder
Search current FDA recognition records without navigating the legacy database interface. Find the recognition number, organization, designation, version, specialty and extent of recognition.
Search four ways
Use a title keyword, designation, product code, or recognition number.
See the exact version
Separate standard designation from the FDA recognition record.
Verify at FDA
Open every official detail page before using a standard in a submission.
Search FDA-recognized consensus standards
Find current FDA recognition records by title, standard designation, FDA product code, or recognition number.
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Recognition is specific
Open the FDA detail record and review the exact version, extent of recognition, transition information, applicable product codes, and any supplemental information. Recognition does not make a standard mandatory or prove a device conforms.
FDA standards database FAQ
Does recognition make a standard mandatory?
Not by itself. Standards can support a submission and a declaration of conformity, but applicability and use depend on the device, submission and current FDA policy.
Why search by product code?
FDA recognition records can identify product codes associated with a standard. This is useful input for a standards strategy, but it is not a complete device-specific applicability determination.
Can I download the standard here?
No. Standards text is generally licensed by the standards organization. This tool searches public FDA recognition metadata and links to the official record.