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Reminder: Starting October 1, 2023, Use of electronic Submission Template and Resource (eSTAR) and CDRH Portal are Required for 510(k) Submissions

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 using eSTAR through the CDRH Portal as noted in the Electronic Submission Template for Medical Device 510(k) Submissions final guidance. eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions.

Use of eSTAR for all 510(k) submissions is part of the FDA’s ongoing commitment to update the 510(k) Program.

Benefits of using eSTAR:

• Enhances the quality of submissions by helping to ensure consistent, quality, comprehensive data for the Center for Devices and Radiological Health (CDRH) premarket review.
• With a standardized format in place, submitters of a 510(k) can ensure that their submissions are complete and premarket reviews will be more efficient.

Questions?

Please contact the DICE helpdesk at DICE@fda.hhs.gov for any questions or concerns.