Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 24, 2014
April 11, 2024
dbfa187c-5a67-45ee-b3ca-a04850a54c6a
Related Documents
Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff
Guidance DocumentDecember 16, 2019Center for Devices and Radiological Health
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentApril 13, 2015Center for Devices and Radiological Health
Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff
Guidance DocumentApril 4, 2014Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox