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FDA Recognized Consensus Standards

Published by U.S. Food and Drug Administration · Updated 07/16/2025 · Quarterly

Last updated
07/16/2025
First published 02/25/2021
Update frequency
Quarterly
Formats
Web only
Coverage
Nationwide
Federal data

About this dataset

This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.

Files and access

Links open the official government source

Links open outside websites we do not control.

Frequently asked questions

Who publishes FDA Recognized Consensus Standards?
U.S. Food and Drug Administration, part of U.S. Department of Health & Human Services, publishes this dataset on Data.gov.
How often is it updated?
The publisher lists the update frequency as quarterly. The last update was on 07/16/2025.
How do I download it?
Use the official source link above to view or request the data.

Where this catalog comes from

Catalog checked 10/24/2026

We list dataset descriptions only. Downloads and APIs link straight to the official government source, which holds the current version and its terms of use.

Source: Data.gov · Last updated 10/24/2026 · Listing only; the data stays with the publisher

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