US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021-Reference-Cited by-同舟云学术

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US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021

Published:2022-08-09 Issue:6 Volume:328 Page:580
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Wunnava Susmitha¹,Miller Timothy A.²,Narang Claire²,Nathan Meena³,Bourgeois Florence T.⁴

Affiliation:

1. Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts

2. Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts

3. Department of Surgery, Harvard Medical School, Boston, Massachusetts

4. Department of Pediatrics, Harvard Medical School, Boston, Massachusetts

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jama/articlepdf/2795037/jama_wunnava_2022_ld_220043_1659634162.5982.pdf

Reference6 articles.

1. Off-label use of medical devices in children.;Jenkins;Pediatrics,2017

2. Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices.;Sutherell;Congenit Heart Dis,2010

3. Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.;Beekman;Pediatrics,2009

4. FDA’s Pediatric Device Consortia: national program fosters pediatric medical device development.;Ulrich;Pediatrics,2013

5. The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation.;Rahimtoola;Circulation,1980

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1. INTEDE 2.0: the metabolic roadmap of drugs;Nucleic Acids Research;2023-11-01

2. Characteristics and Results of Pediatric Medical Device Studies: 2017–2022;Pediatrics;2023-08-11

3. Advancing Equity in Medical Device Development for Children;JAMA Pediatrics;2023-06-01

4. Challenges and solutions to advancing health equity with medical devices;Nature Biotechnology;2023-04-10

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