Preferred Label : Investigational Medical Device;
NCIt related terms : investigational device;
NCIt definition : A device that is the subject of clinical investigation or research to determine the
safety or effectiveness of the device. Investigational devices include transitional
devices (21 CFR 812.3(r)) that are objects of investigations. An investigational device
may be an approved device that is being studied for an unapproved use or efficacy.;
Alternative definition : CDISC-GLOSS: A device that is assessed in a clinical investigation. [REGULATION (EU)
2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical
devices] See also investigational product, medical device.;
Origin ID : C72968;
UMLS CUI : C2346570;
Semantic type(s)
- concept_is_in_subset
