FDA Releases Guidance on Medical Device Submissions and Meetings with FDA Staff

Summary

The Food and Drug Administration (FDA) is releasing a guidance document titled "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff," which outlines the procedures for obtaining FDA feedback on medical device submissions and provides recommendations for Pre-Submission Packages. The guidance aims to facilitate communication between FDA staff and application sponsors, including manufacturers and their representatives.