• FDA Medical Devices
  • FDA Medical Devices Regulation
  • FDA Medical Devices Approvals

Keywords

  • 510k Device Clearances
  • Medical Devices
  • Post-Approval Studies
  • PAS
  • Post-Approval Device
  • Premarket Approval
  • PMA Approvals
  • US Premarket
  • FDCA
  • FDA Device
  • MD Standards

Medical Devices Applications and Approvals Data Package

$635 $439 / YEAR

This data package includes all (510(k)) submissions for medical devices, reporting status of post approval studies, Premarket approval (PMA) applications. it lists also all national and international standards recognized by FDA, 

Benefits
Access to Medical Devices various FDA Applications; Access to FDA Premarket Approval data; Access to updated list of standards recognized by FDA;
Specification
Update Frequency: Weekly
Data Complexity: Simple
Number of Datasets: 5
INCLUDED DATASETS
1. FDA Devices Premarket Approval Summary Review Memos ($79)
2. FDA Medical Device 510k Clearances ($199)
3. FDA Post Approval Studies Database ($79)
4. FDA Premarket Approval Database ($199)
5. FDA Recognized Consensus Standards ($79)