Business · 14/05/2004Updated: 10/17/2026 · 1 min read
FDA Releases Guidance for Pediatric Medical Devices
Summary
The Food and Drug Administration (FDA) has released a guidance document titled 'Premarket Assessment of Pediatric Medical Devices,' outlining the agency's requirements for pediatric medical devices, including the necessary safety and effectiveness data and measures to protect vulnerable patients during clinical trials.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →