Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data

J Pediatr. 2019 Nov;214:209-211. doi: 10.1016/j.jpeds.2019.06.060. Epub 2019 Aug 1.
No abstract available

Keywords: medical devices; real-world data; real-world evidence; regulatory policy.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Child
  • Device Approval / standards*
  • Equipment Safety / standards*
  • Equipment and Supplies / standards*
  • Humans
  • Policy Making*
  • Product Surveillance, Postmarketing / standards
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*