IVD Standards
This section gives information about FDA-recognized national
and international consensus standards for IVD products. For more information,
see Overview of IVD Regulation,
IVD Guidance Documents, and
IVD Advisory Panels.
How does FDA recognize and use consensus standards?
CDRH has published a Guidance Document describing how FDA recognizes and uses consensus standards. The document is called: Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff.
What are the FDA-recognized consensus standards for IVD products?
You can get a list of all FDA-recognized consensus standards at the IVD Standards Webpage.
Where can I get additional information about FDA's Standards Program?
You can get additional information about FDA's Standards Program from the Standards Program website.
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