Watch our free webinar: Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

When and why device manufacturers should use postmarket data to support PMA requirements.

This whitepaper covers the key takeaways from the FDA’s final guidance explaining the best balance between premarket and postmarket data collection during PMA reviews.

Instructor Larry Stevens, RAC, has held almost every field position within the FDA during his 21-year career with the Agency and leverages personal insights to help device manufacturers ensure all PMA requirements are met.

You’ll learn:

  • The key benefits of using postmarket data to support PMA.
  • How postmarket data align with the FDA’s Least Burdensome Approach.
  • When postmarket data is appropriate to illustrate long-term device safety and effectiveness.

45 minute presentation with 15 minutes of Q&A.