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.

MeSH information

Definition | Details | More General Concepts | Related Concepts | More Specific Concepts

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 Food and Drug Administration Device Approval Process Food and Drug Administration Device Approval Process New Device Approval New Device Approval Approval, New Device Approvals, New Device Device Approval, New Device Approvals, New New Device Approvals Food and Drug Administration Device Approval Food and Drug Administration Device Approval New Device Approval Process New Device Approval Process

Below are MeSH descriptors whose meaning is more general than "Device Approval".

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E]
Investigative Techniques [E05]
Evaluation Studies as Topic [E05.337]
Device Approval [E05.337.275]
Health Care [N]
Environment and Public Health [N06]
Public Health [N06.850]
Consumer Product Safety [N06.850.210]
Device Approval [N06.850.210.275]

Below are MeSH descriptors whose meaning is related to "Device Approval".

Below are MeSH descriptors whose meaning is more specific than "Device Approval".

Device Approval
Diagnostic Test Approval

publications

Timeline | Most Recent

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.

Bar chart showing 18 publications over 13 distinct years, with a maximum of 2 publications in 2011 and 2014 and 2017 and 2019 and 2021

To see the data from this visualization as text, click here.

Year	Major Topic	Minor Topic	Total
2003	1	0	1
2009	0	1	1
2011	1	1	2
2012	1	0	1
2014	1	1	2
2016	0	1	1
2017	2	0	2
2018	0	1	1
2019	1	1	2
2020	0	1	1
2021	1	1	2
2022	1	0	1
2025	1	0	1

Below are the most recent publications written about "Device Approval" by people in Profiles.

Williams MM, Smith NR, Uyl-de Groot CA, den Uil CA, Ross JS, Mohamed MO, Mamas MA, Banerjee A, Ko DT, Landon B, Cram P. Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries. Circ Cardiovasc Qual Outcomes. 2025 Apr; 18(4):e011636.

View in: PubMed
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.

View in: PubMed
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.

View in: PubMed
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.

View in: PubMed
Joynt Maddox KE, Bleser WK, Das SR, Desai NR, Ng-Osorio J, O'Brien E, Psotka MA, Wadhera RK, Weintraub WS, Konig M. Value in Healthcare Initiative: Summary and Key Recommendations. Circ Cardiovasc Qual Outcomes. 2020 07; 13(7):e006612.

View in: PubMed
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.

View in: PubMed
Khalid N, Rogers T, Shlofmitz E, Chen Y, Dan K, Torguson R, Weintraub WS, Waksman R. Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel Meeting on Device-Based Therapies for hypertension. Cardiovasc Revasc Med. 2019 Oct; 20(10):891-896.

View in: PubMed
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.

View in: PubMed
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.

View in: PubMed

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