PubMed

Pediatric Device Innovation: An Analysis of Food and Drug Administration Authorizations Over Time.

PMID: 38838107 · 2024-06-05

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ZeitschriftThe Journal of bone and joint surgery. American volume

Jahr2024-06-05

PMID38838107

Zusammenfassung

Despite a tremendous increase in the number of orthopaedic devices authorized by the U.S. Food and Drug Administration (FDA), novel devices designed specifically for the pediatric population remain sparse. Surgeons frequently repurpose adult implants for "off-label" use in pediatric patients, with both legal and technical ramifications. This study seeks to objectively quantify and characterize the nature of pediatric device innovation over time. The FDA employs 4 pathways for assessing safety an

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