an electronic submissions using eSTAR
FDA Update FDA Addresses Electronic Efficiency Reminder: Starting October 1, 2023, Use of and Resource (eSTAR) and CDRH Portal are Required for 510(k) SubmisElectronic Submission Templatesions The U.S. Food and Drug Administration (FDA) is reminding all medical device submitters that starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions