Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Pediatric Product Development, Premarket
Published
June 21, 2016
Last updated
April 8, 2024
Description
This document provides guidance for leveraging clinical data to support the use of medical devices in pediatric populations.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)