"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.
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| Year | Major Topic | Minor Topic | Total |
|---|
| 2008 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 1 |
| 2019 | 0 | 1 | 1 |
| 2021 | 0 | 1 | 1 |
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Below are the most recent publications written about "Device Approval" by people in Profiles.
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Aducanumab and the "post-amyloid" era of Alzheimer research? Neuron. 2021 10 06; 109(19):3045-3047.
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A roadmap for implementation of patient-centered digital outcome measures in Parkinson's disease obtained using mobile health technologies. Mov Disord. 2019 05; 34(5):657-663.
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Training in Structural Heart Disease: Call to Action. Circulation. 2018 07 17; 138(3):225-228.
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Assessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls. J Minim Invasive Gynecol. 2018 Nov - Dec; 25(7):1281-1288.
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A brain-heart team approach to PFO. Catheter Cardiovasc Interv. 2017 11 15; 90(6):879-880.
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SCAI/ACC/HRS institutional and operator requirements for left atrial appendage occlusion. Heart Rhythm. 2016 05; 13(5):e241-e250.
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Assessment of cardiovascular and noncardiovascular medical device recalls. Am J Cardiol. 2014 Jun 01; 113(11):1899-903.
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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.
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Conflating the approval process and clinical research with pharmacoeconomic evaluation. Am J Ther. 2013 Jan; 20(1):1.
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Making America more competitive: a paradigm shift in drug and device development. Am J Ther. 2012 Sep; 19(5):315-6.