Structured Summary
Abstract
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.
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Synonyms
18 entry terms
- Device Approval Process
- Approval Process, Device
- Approval Processes, Device
- Approval, Device
- Approvals, Device
- Device Approval Processes
- Device Approvals
- Process, Device Approval
- Processes, Device Approval
- Food and Drug Administration Device Approval
- Food and Drug Administration Device Approval Process
- New Device Approval
- New Device Approval Process
- Approval, New Device
- Approvals, New Device
- Device Approval, New
- Device Approvals, New
- New Device Approvals
MeSH Record
Aspects Covered
2 allowable subheadings
Indexed with the subheadings legislation & jurisprudence, standards.
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Indexing Annotation
by a govt regulatory agency, not restricted to FDA
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History Note
95
MeSH Record
Previous Indexing
- Consumer Product Safety (1966-1994)
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NLM Classification
WA 289
AMA Style
References
- National Library of Medicine. Device Approval. Medical Subject Headings (MeSH). 2026. Unique ID D018795. http://id.nlm.nih.gov/mesh/2026/D018795
- Device Approval. In: Wikidata. https://www.wikidata.org/wiki/Q70350333