 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 |
|---|
| 2001 | 0 | 1 | 1 | | 2003 | 0 | 1 | 1 | | 2009 | 3 | 0 | 3 | | 2010 | 1 | 0 | 1 | | 2011 | 1 | 0 | 1 | | 2012 | 1 | 0 | 1 | | 2013 | 0 | 1 | 1 | | 2015 | 2 | 2 | 4 | | 2016 | 1 | 0 | 1 | | 2017 | 1 | 2 | 3 | | 2019 | 0 | 1 | 1 | | 2021 | 1 | 0 | 1 |
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Below are the most recent publications written about "Device Approval" by people in Profiles.
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Zafar F, Conway J, Bleiweis MS, Al-Aklabi M, Ameduri R, Barnes A, Bearl DW, Buchholz H, Church S, Do NL, Duffy V, Dykes JC, Eghtesady P, Fisher L, Friedland-Little J, Fuller S, Fynn-Thompson F, George K, Gossett JG, Griffiths ER, Griselli M, Hawkins B, Honjo O, Jeewa A, Joong A, Kindel S, Kouretas P, Lorts A, Machado D, Maeda K, Maurich A, May LJ, McConnell P, Mehegan M, Mong? M, Morales DLS, Murray J, Niebler RA, O'Connor M, Peng DM, Phelps C, Philip J, Ploutz M, Profsky M, Reichhold A, Rosenthal DN, Said AS, Schumacher KR, Si MS, Simpson KE, Sparks J, Louis JS, Steiner ME, VanderPluym C, Villa C. Berlin Heart EXCOR and ACTION post-approval surveillance study report. J Heart Lung Transplant. 2021 04; 40(4):251-259.
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Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Netw Open. 2020 08 03; 3(8):e2014496.
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Giannopoulos S, Armstrong EJ. Newly approved devices for endovascular treatment of femoropopliteal disease: a review of clinical evidence. Expert Rev Cardiovasc Ther. 2019 Oct; 17(10):729-740.
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Chau KH, Kennedy KF, Messenger JC, Garratt KN, Maddox TM, Yeh RW, Kirtane AJ. Uptake of Drug-Eluting Bioresorbable Vascular Scaffolds in Clinical Practice: An NCDR Registry to Practice Project. JAMA Cardiol. 2019 06 01; 4(6):564-568.
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Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein RA, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL. Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. J Vasc Surg. 2018 02; 67(2):637-644.e30.
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Stentz NC, Cooney LG, Sammel M, Shah DK. Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation. Obstet Gynecol. 2017 06; 129(6):1007-1013.
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Forlenza GP. Insulin Infusion Sets and Continuous Glucose Monitoring Sensors: Where the Artificial Pancreas Meets the Patient. Diabetes Technol Ther. 2017 04; 19(4):206-208.
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Yang BW, Iorio ML, Day CS. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center. J Bone Joint Surg Am. 2017 Mar 15; 99(6):e26.
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Bowsher K, Civillico EF, Coburn J, Collinger J, Contreras-Vidal JL, Denison T, Donoghue J, French J, Getzoff N, Hochberg LR, Hoffmann M, Judy J, Kleitman N, Knaack G, Krauthamer V, Ludwig K, Moynahan M, Pancrazio JJ, Peckham PH, Pena C, Pinto V, Ryan T, Saha D, Scharen H, Shermer S, Skodacek K, Takmakov P, Tyler D, Vasudevan S, Wachrathit K, Weber D, Welle CG, Ye M. Brain-computer interface devices for patients with paralysis and amputation: a meeting report. J Neural Eng. 2016 Apr; 13(2):023001.
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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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