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J Pediatr. 2019 Nov;214:209-211. doi: 10.1016/j.jpeds.2019.06.060. Epub 2019 Aug 1.

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

Author information

1
Medical Device Innovation Consortium, Arlington, VA. Electronic address: rfleurence@mdic.org.
2
Children's Hospital of Philadelphia, Philadelphia, PA.
3
US Food and Drug Administration, Silver Spring, MD.

KEYWORDS:

medical devices; real-world data; real-world evidence; regulatory policy

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