US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021
Overview
Overview
Journal
JAMA
Publisher
American Medical Association
Specialty
General Medicine
Date
2022 Aug 9
PMID
35943478
Authors
Affiliations
Affiliations
Soon will be listed here.
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References
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Sutherell J, Hirsch R, Beekman 3rd R
. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis. 2010; 5(1):2-7.
DOI: 10.1111/j.1747-0803.2009.00364.x.
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2.
. Off-Label Use of Medical Devices in Children. Pediatrics. 2016; 139(1).
DOI: 10.1542/peds.2016-3439.
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3.
Ulrich L, Joseph F, Lewis D, Koenig R
. FDA's pediatric device consortia: national program fosters pediatric medical device development. Pediatrics. 2013; 131(5):981-5.
DOI: 10.1542/peds.2012-1534.
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4.
Rahimtoola S, Rahmoeller G
. The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation. Circulation. 1980; 62(5):919-24.
DOI: 10.1161/01.cir.62.5.919.
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Beekman 3rd R, Duncan B, Hagler D, Jones T, Kugler J, Moore J
. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions. Pediatrics. 2009; 124(1):e155-62.
DOI: 10.1542/peds.2008-3726.
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