eSTAR
eSTAR is the electronic Submission Template and Resource: an interactive PDF form that guides an applicant through building a medical device submission. It is not a document template. It is a structured form with built-in logic, integrated FDA databases and completeness checks. It has been mandatory for 510(k) submissions since 1 October 2023, and for De Novo requests since 1 October 2025.
FDA eSTAR guidance; 87 FR 57910
At a glance
| What it is | An interactive PDF form with logic, prompts and integrated FDA databases. |
|---|---|
| Mandatory for | 510(k) and De Novo submissions to CDRH or CBER, unless exempted. Also 510(k)/De Novo for combination products, and Dual 510(k)/CLIA Waiver submissions. |
| Voluntary for | PMA and its supplements, Q-Submissions, IDEs and 513(g) requests. |
| 510(k) mandatory since | 1 October 2023. |
| De Novo mandatory since | 1 October 2025. |
| How it is transmitted | 510(k) and De Novo must go through the CDRH Portal. CBER uses the Electronic Submission Gateway. |
| Size limits | The CDRH Portal cannot receive individual files larger than 4 GB, or PDFs with an attachment larger than 1 GB. |
| Does it go through RTA? | No. eSTAR submissions are technically screened instead. See below. |
Technical screening, not Refuse to Accept
FDA states that because a submission properly prepared with an electronic submission template should be complete, eSTAR submissions are not anticipated to undergo a refuse to accept process. The CDRH Portal verifies completeness automatically at upload, and an incomplete eSTAR will not be accepted by the Portal at all.
What replaces it is a virus scan and a technical screening, anticipated within 15 days of FDA receiving the eSTAR.
If the eSTAR does not pass technical screening, FDA notifies the submitter by email, identifies the incomplete information, and places the submission on hold. If a complete replacement eSTAR is not received within 180 days of that notification, FDA considers the submission withdrawn and closes it.
FDA attaches an explicit condition to this benefit: the benefits of eSTAR, including no RTA review, depend on accurate responses, and FDA intends to verify their accuracy. Inaccurate responses — for example a wrong dropdown selection that causes eSTAR to omit later questions — may lead to an early hold.
Because eSTAR is now mandatory for both 510(k) and De Novo, the traditional acceptance review and RTA process applies in practice only to eCopy submissions.
Questions people ask
Where do we get eSTAR?
From FDA's eSTAR Program page. It is free. Separate templates exist for different submission types.
Can we submit an eSTAR by email or post?
510(k) and De Novo submissions must go through the CDRH Portal. An incomplete eSTAR sent by mail or through the Electronic Submission Gateway is placed on hold for up to 180 days.
Does eSTAR mean FDA is less likely to reject the submission?
It removes one category of failure — administrative incompleteness — because the form will not let you submit without the required fields. It does not affect the substantive review, where the predicate comparison and the performance data are assessed.
Is there a fee for eSTAR?
No. eSTAR is a template, not a submission type. The applicable user fee is the one for the submission itself.
What if our submission does not fit the template?
eSTAR accommodates attachments, and the template covers the submission types it is mandatory for. Where a specific exemption applies, FDA sets those out in section VI.A of the eSTAR guidance.