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FDA eManufacturing Terminology
Terminology developed to support manufacturing efforts of the FDA. (NCI Thesaurus)
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Terminology developed to support the efforts of Electronic Common Technical Documents.
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.