Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 7, 2023
September 6, 2023
2dec4ff6-6af1-41a5-87fb-193c6bb8a13f
Related Documents
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJune 5, 2025Center for Devices and Radiological Health
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 7, 2023Center for Devices and Radiological Health
Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 7, 2023Center 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