Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

PubMed

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

PMID: 38838107 ·

J, o, n, a, t, h, a, n, , D, u, b, i, n, ;, , K, r, i, s, h, , S, a, r, d, e, s, a, i, ;, , C, a, l, e, b, , G, r, o, t, e, ;, , C, a, r, o, l, i, n, e, , T, o, u, g, a, s, ;, , K, a, t, h, e, r, i, n, e, , B, r, a, n, c, h, e, ;, , N, o, r, m, a, n, , O, t, s, u, k, a

RevistaThe Journal of bone and joint surgery. American volume
Ano
PMID38838107

Resumo

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

Fonte oficial

Ver no PubMed →

Dados provenientes do PubMed / NCBI. Para consultar o texto integral e as informações mais recentes, recorra sempre ao registo oficial.

↑