"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 |
|---|
| 2007 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2011 | 0 | 1 | 1 |
| 2012 | 1 | 1 | 2 |
| 2013 | 0 | 2 | 2 |
| 2015 | 1 | 0 | 1 |
| 2016 | 0 | 1 | 1 |
| 2018 | 0 | 1 | 1 |
| 2020 | 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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Basic principles of viscoelastic testing. Transfusion. 2020 10; 60 Suppl 6:S1-S9.
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Update on the status of infrarenal AAA devices. J Cardiovasc Surg (Torino). 2018 Jun; 59(3):330-335.
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Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular Tachycardia: Post-Approval THERMOCOOL VT Trial. J Am Coll Cardiol. 2016 Feb 16; 67(6):674-683.
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The challenging landscape of medical device approval in localized prostate cancer. Nat Rev Urol. 2016 Feb; 13(2):91-8.
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The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process. Am J Gastroenterol. 2014 Oct; 109(10):1508-12.
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The inferior vena cava filter: how could a medical device be so well accepted without any evidence of efficacy? JAMA Intern Med. 2013 Apr 08; 173(7):493-5; discussion 495.
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Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine. Am Soc Clin Oncol Educ Book. 2013; 118-25.
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Evaluating imaging and computer-aided detection and diagnosis devices at the FDA. Acad Radiol. 2012 Apr; 19(4):463-77.
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Reversals of established medical practices: evidence to abandon ship. JAMA. 2012 Jan 04; 307(1):37-8.
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Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities. Radiology. 2011 Jun; 259(3):875-84.