Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 28, 2022
September 27, 2022
cba45f13-a519-4f3d-b5c9-5415b512670e
Related Documents
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 28, 2022Center for Devices and Radiological Health
Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentOctober 2, 2023Center for Devices and Radiological Health
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentMarch 31, 2025Center 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