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

New Device Approval Process

Food and Drug Administration Device Approval Process

New Device Approval

Food and Drug Administration Device Approval

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 Harvard Catalyst Profiles by year, and whether "Device Approval" was a major or minor topic of these publication.

Bar chart showing 122 publications over 25 distinct years, with a maximum of 14 publications in 2015

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

Year	Major Topic	Minor Topic	Total
1996	0	1	1
1997	1	0	1
2000	1	1	2
2001	0	3	3
2002	0	2	2
2004	0	2	2
2005	3	1	4
2006	1	2	3
2007	3	1	4
2008	2	1	3
2009	2	2	4
2010	3	1	4
2011	2	2	4
2012	7	5	12
2013	1	5	6
2014	7	4	11
2015	8	6	14
2016	3	2	5
2017	3	3	6
2018	2	2	4
2019	2	6	8
2020	0	2	2
2021	4	2	6
2022	5	2	7
2023	4	0	4

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

Coverage for Emerging Technologies - Bridging Regulatory Approval and Patient Access. N Engl J Med. 2023 Nov 30; 389(22):2021-2024.

View in: PubMed
Time to publication of cost-effectiveness analyses for medical devices. Am J Manag Care. 2023 05; 29(5):265-268.

View in: PubMed
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 01 10; 329(2):144-156.

View in: PubMed
High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021. JAMA Pediatr. 2023 01 01; 177(1):98-100.

View in: PubMed
Shoulder arthroplasty device clearance: an ancestral network analysis. J Shoulder Elbow Surg. 2023 Mar; 32(3):671-676.

View in: PubMed
US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021. JAMA. 2022 08 09; 328(6):580-582.

View in: PubMed
Voting behavior during FDA Medical Device Advisory Committee panel meetings. PLoS One. 2022; 17(6):e0267134.

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The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology. J Am Acad Orthop Surg. 2022 Jul 15; 30(14):658-667.

View in: PubMed
Pivotal clinical trials with patient-reported outcome measures in premarket approval applications for high-risk medical devices from 2005 to 2018: Review, examples, and regulatory considerations. Contemp Clin Trials. 2022 05; 116:106757.

View in: PubMed
Reporting Device-Associated Death Events to the FDA-Reply. JAMA Intern Med. 2022 04 01; 182(4):462-463.

View in: PubMed

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