Business · 21/06/2022Updated: 10/17/2026 · 1 min read

FDA Announces Pilot Program to Improve 510(k) Submission Preparation and Review

Summary

The FDA's Center for Biologics Evaluation and Research is launching a pilot program to enhance consistency and efficiency in the preparation and review of premarket notification submissions, allowing industry sponsors to provide feedback on the Electronic Submission Template and Resource Pilot Program

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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