Free official FDA standards search · No signupFDA 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 FDA-recognized consensus standards
Find current FDA recognition records by title, standard designation, FDA product code, or recognition number.
How to use FDA recognition records
An FDA-recognized consensus standard is a voluntary standard for which FDA publishes a recognition decision. The detail record identifies the recognized version, extent and supporting information — separate the standard designation from the FDA recognition record before citing either in a submission.
Recognition records can identify product codes associated with a standard. That is useful input for a standards strategy, but it is not a complete device-specific applicability determination, and standards text itself remains licensed by the standards organization.
- 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.
- 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.
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