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Striking the Right Balance Between Premarket and Postmarket Data for Device Manufacturers

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

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

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