Draft Guidance on Using Patient Preference Information Goes Beyond Premarket Submissions for Devices
September 19, 2024 at 11:55 AM EST
New draft FDA guidance is intended to help medical device sponsors and other interested parties understand the principal concepts to consider when choosing to collect and submit patient preference information (PPI) concerning devices, which the agency said “can be used across the total product life cycle.”
PPI can be useful in the FDA’s review of investigational device exempt... Read More
