Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications

IMPORTANCE: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. OBJECT...

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Bibliographic Details
Published in:JAMA Netw Open
Main Authors: Lee, Samuel J., Cho, Lauren, Klang, Eyal, Wall, James, Rensi, Stefano, Glicksberg, Benjamin S.
Format: Artigo
Language:Inglês
Published: American Medical Association 2021
Subjects:
Original Investigation
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC8220494/
https://ncbi.nlm.nih.gov/pubmed/34156454
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2021.12562
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