"Device Approval" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus,
MeSH (Medical Subject Headings). Descriptors are arranged in a hierarchical structure,
which enables searching at various levels of specificity.
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.
| Descriptor ID |
D018795
|
| MeSH Number(s) |
E05.337.275 N06.850.210.275
|
| Concept/Terms |
Device Approval- Device Approval
- Approval, Device
- Approvals, Device
- Device Approvals
- Device Approval Process
- Approval Process, Device
- Approval Processes, Device
- Device Approval Processes
- Process, Device Approval
- Processes, Device Approval
New Device Approval- New Device Approval
- Approval, New Device
- Approvals, New Device
- Device Approval, New
- Device Approvals, New
- New Device Approvals
|
Below are MeSH descriptors whose meaning is more general than "Device Approval".
Below are MeSH descriptors whose meaning is more specific than "Device Approval".
This graph shows the total number of publications written about "Device Approval" by people in this website by year, and whether "Device Approval" was a major or minor topic of these publications.
To see the data from this visualization as text,
click here.
| Year | Major Topic | Minor Topic | Total |
|---|
| 1995 | 0 | 1 | 1 |
| 2001 | 0 | 1 | 1 |
| 2009 | 0 | 1 | 1 |
| 2010 | 0 | 1 | 1 |
| 2011 | 1 | 0 | 1 |
| 2014 | 0 | 1 | 1 |
| 2016 | 1 | 0 | 1 |
| 2018 | 1 | 0 | 1 |
| 2021 | 0 | 1 | 1 |
| 2023 | 1 | 0 | 1 |
| 2024 | 0 | 1 | 1 |
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click here.
Below are the most recent publications written about "Device Approval" by people in Profiles.
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Pediatric Device Clinical Trials Activity: 1999-2022. Pediatrics. 2024 Aug 01; 154(2).
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An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use. J Am Coll Radiol. 2023 08; 20(8):738-741.
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False positive Influenza rapid tests using newly EUA cleared multiplex assay in a low prevalence setting. J Med Virol. 2021 06; 93(6):3285.
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Social media and Essure hysteroscopic sterilization: a perfect storm. Fertil Steril. 2019 06; 111(6):1105-1106.
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US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg. 2019 01; 269(1):30-36.
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Pediatric and congenital electrophysiology society initiative on device needs in pediatric electrophysiology. Heart Rhythm. 2019 04; 16(4):e39-e46.
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Special Report: The American Academy of Ophthalmology Task Force for Developing Novel End Points for Premium Intraocular Lenses Introduction. Ophthalmology. 2017 01; 124(1):133-134.
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An anthropomorphic spine phantom for proton beam approval in NCI-funded trials. J Appl Clin Med Phys. 2014 May 08; 15(3):4742.
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Postapproval outcomes of juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft. J Vasc Surg. 2014 Aug; 60(2):295-300.
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Solitaire Flow Restoration thrombectomy for acute ischemic stroke: retrospective multicenter analysis of early postmarket experience after FDA approval. Neurosurgery. 2013 Jul; 73(1):19-25; discussion 25-6.