device approval

Preferred Label : device approval;

MeSH definition : Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.;

MeSH synonym : approval, device; approvals, device; device approvals; device approval process; approval process, device; approval processes, device; device approval processes; process, device approval; processes, device approval;

MeSH hyponym : new device approval process; food and drug administration device approval; new device approval; food and drug administration device approval process; Approval, New Device; Approvals, New Device; Device Approval, New; Device Approvals, New; New Device Approvals;

MeSH annotation : by a govt regulatory agency, not restricted to FDA;

Details

Origin ID

D018795;

UMLS CUI

C0243018;

Allowable qualifiers
- legislation and jurisprudence [MeSH Qualifier]
- standards [MeSH Qualifier]
Automatic exact mappings (from CISMeF team)
- Device Approval [DeCS]
Metaterm(s)
- equipment and supplies [CISMeF Metaterm]
Record concept(s)
- device approval [MeSH concept]
- food and drug administration device approval [MeSH concept]
- food and drug administration device approval process [MeSH concept]
- new device approval [MeSH concept]
- new device approval process [MeSH concept]
See also (suggested by CISMeF)
- accreditation [MeSH Descriptor]
- technology assessment, biomedical [MeSH Descriptor]
Semantic type(s)
- Governmental or Regulatory Activity [UMLS semantic type]

Keyword's position in hierarchy(ies) :

Main resources

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