Preferred Label : Device Manufacture;
NCIt related terms : manufacturer (device);
NCIt definition : A person or entity that designs, manufactures, fabricates, assembles, or processes
a finished device.;
Alternative definition : CDISC-GLOSS: Any person or entity who manufactures, prepares, propagates, compounds,
assembles, or processes a device by chemical, physical, biological, or other procedure.
The term includes any person who either (1) Repackages or otherwise changes the container,
wrapper, or labeling of a device in furtherance of the distribution of the device
from the original place of manufacture; (2) Initiates specifications for devices that
are manufactured by a second party for subsequent distribution by the person initiating
the specifications; (3) Manufactures components or accessories that are devices that
are ready to be used and are intended to be commercially distributed and intended
to be used as is, or are processed by a licensed practitioner or other qualified person
to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer.
[after 21 CFR 803.3, FDA] See also manufacturer (drug).;
NCI Metathesaurus CUI : CL935770;
Origin ID : C156625;
UMLS CUI : C4744950;
Semantic type(s)
- concept_is_in_subset
