Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments

摘要

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing a pilot program for sponsors of CBER premarket notification (510(k)) submissions that wish to use the voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program. CBER's voluntary eSTAR Pilot Program is intended to improve consistency and efficiency in both industry's preparation and FDA's review of premarket notification (510(k)) submissions. During CBER's voluntary eSTAR Pilot Program, participants will have the opportunity to provide input to FDA on the eSTAR Pilot Program for submissions to CBER.