"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 |
|---|
| 2005 | 2 | 0 | 2 |
| 2009 | 0 | 1 | 1 |
| 2011 | 1 | 0 | 1 |
| 2013 | 0 | 1 | 1 |
| 2017 | 3 | 0 | 3 |
| 2018 | 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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Resnic FS, Matheny ME. Medical Devices in the Real World. N Engl J Med. 2018 Feb 15; 378(7):595-597.
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Cook JL, Colvin M, Francis GS, Grady KL, Hoffman TM, Jessup M, John R, Kiernan MS, Mitchell JE, Pagani FD, Petty M, Ravichandran P, Rogers JG, Semigran MJ, Toole JM. Recommendations for the Use of Mechanical Circulatory Support: Ambulatory and Community Patient Care: A Scientific Statement From the American Heart Association. Circulation. 2017 06 20; 135(25):e1145-e1158.
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Eijkholt M, Cabrera LY, Ramirez-Zamora A, Pilitsis JG. Shaking Up the Debate: Ensuring the Ethical Use of DBS Intervention Criteria for Mid-Stage Parkinson's Patients. Neuromodulation. 2017 Jul; 20(5):411-416.
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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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Simons JP, Shue B, Flahive JM, Aiello FA, Steppacher RC, Eaton EA, Messina LM, Schanzer A. Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States. J Vasc Surg. 2017 05; 65(5):1260-1269.
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Psotka MA, von Maltzahn R, Anatchkova M, Agodoa I, Chau D, Malik FI, Patrick DL, Spertus JA, Wiklund I, Teerlink JR. Patient-Reported Outcomes in Chronic?Heart Failure: Applicability for Regulatory Approval. JACC Heart Fail. 2016 10; 4(10):791-804.
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Gounis MJ, Wakhloo AK, Chueh JY. Preclinical investigations for thrombectomy devices--does it translate to humans? Stroke. 2013 Jun; 44(6 Suppl 1):S7-S10.
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Lim HW, James WD, Rigel DS, Maloney ME, Spencer JM, Bhushan R. Adverse effects of ultraviolet radiation from the use of indoor tanning equipment: time to ban the tan. J Am Acad Dermatol. 2011 Apr; 64(4):e51-60.
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Spear SL, Parikh PM, Goldstein JA. History of breast implants and the food and drug administration. Clin Plast Surg. 2009 Jan; 36(1):15-21, v.
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Hauser RG, Maron BJ. Lessons from the failure and recall of an implantable cardioverter-defibrillator. Circulation. 2005 Sep 27; 112(13):2040-2.