 
Today, the U.S. Food and Drug Administration (FDA) issued minor updates to the final guidance: Electronic Submissions Template for Medical Devices 510(k) Submissions. The updates are to support the use of the Electronic Submission Template and Resource (eSTAR) through the CDRH Portal. As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
Use of eSTAR for all 510(k) submissions is part of the FDA’s ongoing efforts to modernize the 510(k) Program, and implement MDUFA V and 745A(b) of the Federal Food, Drug, and Cosmetic Act.
This final guidance provides the following minor updates:
- Withdrawal requests, which have previously been submitted via email continue to be exempt from electronic submission requirements.
- While use of eSTAR will be required starting on October 1, 2023, there are currently known technical reasons that preclude electronic submission via the CDRH Portal and impacted submissions will need to be mailed to the CDRH Document Control Center.
eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. With a standardized format, submitters can ensure their submissions are complete, and the FDA can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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