Check eligibility of your 510(k)Submission by referring to the Electronic Submission Template or Medical Device 510(k) Submissions FDA Guidance.
Download the most up-to-date eSTAR PDF template from the FDA website.
Follow the embedded instructions in the eSTAR template structure and fill in the required information about the subject device.
Attach all the necessary documents like device description, mechanical test reports, biocompatibility reports, clinical data, and draft labeling into the eSTAR Template.
To ensure file size and format compliance, combine attachments of each section to reduce separate files. A general recommendation would be to compress all the PDF attachments to meet the 4 GB limit, compatible image/video formats for the eSTAR Template.
Fill out required forms for eg: Truthful & Accurate statement (Form 3514), 510(k)Summary, Declaration of Conformity, and the Indications for Use (Form 3881) within the eSTAR template.
After you have entered all the information and attachments in your eSTAR submission, the status message at the top will indicate "eSTAR Complete." If you submit your eSTAR submission while the status message still indicates "eSTAR Incomplete," the FDA may put your eSTAR submission on "eCopy Hold."
Save a local copy of the completed eSTAR PDF and submit electronically based on device type (CDRH or CBER). For CDRH, send eSTAR premarket submissions online through the CDRH Portal or by mail to the appropriate address.
All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER.
After submission, the FDA will conduct a technical screening of the eSTAR 510(k) submission and update the status to “TSOK” - Technical Screening OK or “TSIC” - Technical Screening Incomplete and is put on an early Technical Screening hold for 180 days, until a complete replacement eSTAR is submitted.