Recent Advancement in Pediatric Medical Device Development and Approval of Usfda

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Review highlights innovations in pediatric medical devices, including 3D printing and regulatory pathways for approval.

Major advancements in pediatric medical devices have occurred, addressing the specific needs of children and infants.
Recent innovations include 3D printing of devices and the use of pediatric-specific biomarkers for early disease diagnosis.
The assessment covers various regulatory pathways like 510(k), PMA, and HDE that facilitate pediatric device approval.
Efforts continue to bridge the innovation gap in pediatric care, enhancing the availability of effective medical devices for children.

PRASAD et al. (2025) studied this question.

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