This resource is the US FDA (Food and Drug Administration) guidance on the electronic submission template (eSTAR) for 510(k) submissions. Since 1 October 2023, 510(k) submissions must in principle be submitted electronically using eSTAR.
About this document
eSTAR is an interactive PDF submission template provided by the FDA. It guides companies through each section of the submission, filling in information and uploading attachments, with built-in completeness checks. Submissions using eSTAR are no longer subject to the former Refuse to Accept (RTA) review, helping to reduce submissions being returned as incomplete.
Applicable products and users
- All medical devices entering the US market via 510(k)
- Regulatory staff responsible for preparing and submitting FDA submissions
Main contents
- Scope of eSTAR and the mandatory implementation date
- Requirements for completing each section of the template
- Attachment formats and submission route (CDRH Portal)
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Related articles
- US FDA Medical Device 510(k) Submissions
- FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained
- Similarities and Differences in FDA and NMPA Electronic Submissions
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.