"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
|
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 |
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2003 | 2 | 0 | 2 |
2009 | 0 | 1 | 1 |
2010 | 0 | 1 | 1 |
2011 | 1 | 1 | 2 |
2012 | 1 | 0 | 1 |
2014 | 0 | 1 | 1 |
2016 | 0 | 1 | 1 |
2017 | 1 | 0 | 1 |
2018 | 0 | 1 | 1 |
2019 | 0 | 1 | 1 |
2021 | 1 | 1 | 2 |
2022 | 1 | 0 | 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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Potnis KC, Ross JS, Aneja S, Gross CP, Richman IB. Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations. JAMA Intern Med. 2022 12 01; 182(12):1306-1312.
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Samdani AF, Pahys JM, Ames RJ, Grewal H, Pelletier GJ, Hwang SW, Betz RR. Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study. J Bone Joint Surg Am. 2021 09 01; 103(17):1611-1619.
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Goh GS, Tornetta P, Parvizi J. Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market: Insights from an FDA Workshop on Orthopaedic Device-Related Infections. J Bone Joint Surg Am. 2021 08 04; 103(15):e57.
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Samsky M, Krucoff M, Althouse AD, Abraham WT, Adamson P, Aguel F, Bilazarian S, Dangas GD, Gilchrist IC, Henry TD, Hochman JS, Kapur NK, Laschinger J, Masters RG, Michelson E, Morrow DA, Morrow V, Ohman EM, Pina I, Proudfoot AG, Rogers J, Sapirstein J, Senatore F, Stockbridge N, Thiele H, Truesdell AG, Waksman R, Rao S. Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock. Am Heart J. 2020 01; 219:1-8.
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Nandra K, Ing R. Safety of orogastric tubes in foregut and bariatric surgery. Surg Endosc. 2018 10; 32(10):4068-4070.
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Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015. Ophthalmology. 2017 08; 124(8):1237-1246.
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Tchantchaleishvili V, Phillips SJ. Update in Artificial Heart Technology: Are We There Yet? Artif Organs. 2016 Dec; 40(12):1099-1100.
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Goudra BG, Singh PM. SEDASYS, sedation, and the unknown. J Clin Anesth. 2014 Jun; 26(4):334-6.
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Gray WA, Simonton CA, Verta P. Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel meeting on the ACCULINK and ACCUNET Carotid Artery Stent System. Circulation. 2012 May 08; 125(18):2256-64.
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Starling RC, Naka Y, Boyle AJ, Gonzalez-Stawinski G, John R, Jorde U, Russell SD, Conte JV, Aaronson KD, McGee EC, Cotts WG, DeNofrio D, Pham DT, Farrar DJ, Pagani FD. Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2011 May 10; 57(19):1890-8.