FDA Device Classification

The class of medical device as determined by the US Food and Drug Administration, based upon the level of control necessary to ensure safety and effectiveness (21 CFR 860). (NCI Thesaurus)

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FDA Classified Non-traditional Sterilization Method

Sterilization methods that do not have a long history of safe and effective use and for which there are no FDA-recognized standards,…

FDA Center For Devices and Radiological Health Terminology

Terminology used in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post…

FDA CDRH GUDID Terminology

A set of terminology created to support the efforts of the FDA CDRH Global Unique Device Identification Database project.

FDA Approval

A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical…

FDA Act Type Terminology

Terminology codelist used to describe the principal observations for human clinical and non-human non-clinical studies for the FDA CDA guide.

FDA

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional…