Device Approval
"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
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MeSH Number(s) |
E05.337.275 N06.850.210.275
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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
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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 |
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2008 | 1 | 0 | 1 | 2009 | 1 | 0 | 1 | 2010 | 3 | 0 | 3 | 2011 | 2 | 0 | 2 | 2012 | 1 | 0 | 1 | 2013 | 1 | 1 | 2 | 2014 | 0 | 1 | 1 | 2015 | 1 | 0 | 1 | 2017 | 0 | 1 | 1 | 2018 | 0 | 2 | 2 | 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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Musiek ES, Bennett DA. Aducanumab and the "post-amyloid" era of Alzheimer research? Neuron. 2021 10 06; 109(19):3045-3047.
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Espay AJ, Hausdorff JM, Sánchez-Ferro Á, Klucken J, Merola A, Bonato P, Paul SS, Horak FB, Vizcarra JA, Mestre TA, Reilmann R, Nieuwboer A, Dorsey ER, Rochester L, Bloem BR, Maetzler W. 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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Kavinsky CJ, Poulin MF, Mack MJ. Training in Structural Heart Disease: Call to Action. Circulation. 2018 07 17; 138(3):225-228.
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Galhotra S, Maurice J. 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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Garratt KN, Horlick E, Kavinsky C, Rosenfield K. A brain-heart team approach to PFO. Catheter Cardiovasc Interv. 2017 11 15; 90(6):879-880.
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Kavinsky CJ, Kusumoto FM, Bavry AA, Bailey SR, Ellenbogen KA, Hess PL, Lustgarten DL, Moussa ID, Spies C. SCAI/ACC/HRS institutional and operator requirements for left atrial appendage occlusion. Heart Rhythm. 2016 05; 13(5):e241-e250.
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Somberg JC, McEwen P, Molnar J. Assessment of cardiovascular and noncardiovascular medical device recalls. Am J Cardiol. 2014 Jun 01; 113(11):1899-903.
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Mokin M, Dumont TM, Veznedaroglu E, Binning MJ, Liebman KM, Fessler RD, To CY, Turner RD, Turk AS, Chaudry MI, Arthur AS, Fox BD, Hanel RA, Tawk RG, Kan P, Gaughen JR, Lanzino G, Lopes DK, Chen M, Moftakhar R, Billingsley JT, Ringer AJ, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. 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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Somberg JC. Conflating the approval process and clinical research with pharmacoeconomic evaluation. Am J Ther. 2013 Jan; 20(1):1.
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Somberg JC. Making America more competitive: a paradigm shift in drug and device development. Am J Ther. 2012 Sep; 19(5):315-6.
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