"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 |
|---|
| 2004 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2017 | 6 | 1 | 7 |
| 2018 | 3 | 5 | 8 |
| 2019 | 5 | 1 | 6 |
| 2020 | 1 | 1 | 2 |
| 2021 | 0 | 1 | 1 |
To return to the timeline, click here.
Below are the most recent publications written about "Device Approval" by people in Profiles.
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[The Policy and Practice of Medical Device Emergency Approval at the Local Level under the Circumstance of COVID-19 Disease]. Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Jul 30; 45(4):429-433.
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Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic. Am J Law Med. 2021 07; 47(2-3):291-326.
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False positive Influenza rapid tests using newly EUA cleared multiplex assay in a low prevalence setting. J Med Virol. 2021 06; 93(6):3285.
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How COVID unlocked the power of RNA vaccines. Nature. 2021 01; 589(7841):189-191.
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China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval. Bioanalysis. 2021 Jan; 13(2):69-76.
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COVID-19: Pay attention to unverified devices. Minerva Anestesiol. 2021 04; 87(4):491-492.
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Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities. Clin Ther. 2021 01; 43(1):124-139.
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Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients. Chest. 2021 02; 159(2):724-732.
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An industry update: the latest developments in therapeutic delivery covering May 2020. Ther Deliv. 2020 09; 11(9):541-546.
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Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples. Clin Chim Acta. 2020 Nov; 510:73-78.