What is the FDA’s eSTAR program?
The portal for FDA medical device submissions is the electronic Submission Template and Resource (eSTAR). eSTAR provides an interactive PDF form that guides users through a complete medical device submission. The eSTAR program was created to help the FDA conduct premarket reviews more efficiently, which promotes timely access to safe, effective, and high-quality medical devices.
The FDA’s eSTAR webpage has information on accessing eSTAR and helps with troubleshooting any issues. Some required forms (ex: Form FDA 3881 “Indications for USE” or Form FDA 3514 “Premarket Review Cover Sheet”) are built into the eSTAR template. Following the Adobe Acrobat Pro directions for attaching documents is important, and allows linking of one attachment to another within an eSTAR. The FDA strongly discourages submitting any document outside of an applicant’s given eSTAR (except where necessary for CDISC files, DICOM files, or large media files). Note that the status message at the top of the eSTAR template must indicate “eSTAR COMPLETE” before the submission will be accepted. For CDRH, send eSTAR premarket submissions online through the CDRH Portal; for CBER send eSTAR premarket submissions online through the FDA’s ESG.
How does an applicant know whether eSTAR use is mandatory or voluntary?
Some submissions require the use of eSTAR, while some submissions allow but do not require eSTAR use. The table below is applicable for medical device submissions to CDRH or CBER.
| Mandatory | Voluntary |
|---|---|
| Medical device premarket notifications: 510(k) and De Novo (unless exempted) | Medical device premarket approval applications and supplement types: Original PMAs, PMA Panel Track Supplements, PMA Real-Time Supplements, PMA 180 Day Supplements and 30-Day Notice/135-Day Supplements. |
| Dual 510(k)/CLIA Waiver IVD submissions to CDRH | Q-Submissions (Q-Sub), including Pre-Submissions, Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings, and Accessory Classification Requests |
| Investigational Device Exemptions (IDE) | |
| 513(g) Requests for Information |
Link to FDA site: Mandatory vs Voluntary eSTAR submission
Current Versions of eSTAR
There are three current eSTAR versions:
- Non-In Vitro Diagnostic eSTAR
- In Vitro Diagnostic eSTAR
- Early Submission Requests eSTAR (“PreSTAR”)
PreSTAR is intended for both nIVDs and IVDs submitted to CDRH or CBER.
A recent update from the FDA’s eSTAR Program, is that the non-In Vitro Diagnostic (nIVD) and In Vitro Diagnostic (IVD) eSTARs now include the content of the Human Factors Content Guidance, published on May 29, 2026, and effective on August 1, 2026.
It is also a new development that PreSTAR is now available for voluntary use with these additional Q-Submission types: Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings, and Accessory Classification Requests.
eSTAR is an ever-expanding tool and we anticipate greater use in the future. See other FDA news items summarized by SoftwareCPR here.
