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FDA eCTD Terminology
Terminology developed to support the efforts of Electronic Common Technical Documents. (NCI Thesaurus)
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A number assigned by the FDA to a device during Registration and Listing.
The class of medical device as determined by the US Food and Drug Administration, based upon the level of control necessary to…
Sterilization methods that do not have a long history of safe and effective use and for which there are no FDA-recognized standards,…
Terminology used in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post…
A set of terminology created to support the efforts of the FDA CDRH Global Unique Device Identification Database project.
A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical…
