United States medical device QA/RA blog

News and commentary on regulatory changes.

Updated list of recognized Standards published by US FDA

The Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration has published an updated list of recognized standards used in premarket reviews of medical device submissions. This list is generally updated every 3-6 months by FDA. You can download the most recent list published in the Federal Register.


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