Usage Examples
- The team pushed the finalized eSTAR to the CDRH Portal ahead of the user-fee deadline.
- Three attachment questions were still unanswered, so the template never flipped to eSTAR Complete.
- FDA is retiring the version we drafted in, so we exported the XML and imported it into eSTAR 7.0.
What is eSTAR (electronic Submission Template And Resource)?
eSTAR is FDA's interactive PDF submission template, mandatory for 510(k) and De Novo submissions, that the CDRH Portal rejects until every applicable field and attachment is complete. eSTAR use stays voluntary for PMA, IDE, 513(g), and Q-Submissions.
eSTAR exists because FDA reviewers were burning acceptance-review cycles on device submissions that were merely incomplete rather than scientifically deficient. Section 745A(b) of the FD&C Act, added by FDARA section 207, requires device submissions to arrive in an electronic format FDA specifies by guidance, and CDRH built eSTAR to push completeness checking upstream into the sponsor's own preparation work.
eSTAR covers 510(k) and De Novo submissions to CDRH and CBER, including combination-product filings and dual 510(k)/CLIA Waiver IVD submissions, and is available on a voluntary basis for original PMAs, PMA supplements, IDEs, 513(g) requests, and Q-Submissions. eSTAR does not cover interactive review responses, appeals, substantive summary requests, change-in-correspondent amendments, add-to-files, or withdrawal requests, all of which FDA exempted from the electronic submission requirement.
eSTAR is completed offline in Adobe Acrobat Pro, PDF-XChange Editor, or FoxIt PDF Reader, never in a browser, and displays "eSTAR COMPLETE" only once every applicable question is answered and every required attachment is present. eSTAR files then move to CDRH through the CDRH Portal, where virus scanning and a 15-day technical screening take the place of the old Refuse to Accept review.
Not to be confused with
- 510(k)
- a 510(k) is the premarket notification FDA acts on and the clearance decision that follows. eSTAR is the mandated container that notification must arrive in, so an eSTAR can be complete months before the 510(k) is cleared or refused.
- RTA (Refuse to Accept)
- RTA was the reviewer-run checklist that screened eCopy 510(k)s for completeness. eSTAR submissions are not anticipated to undergo RTA; FDA instead runs virus scanning plus a technical screening that checks whether responses actually match the device and whether each attachment fits its question.
- PMA
- PMA applications may be built in eSTAR but are not required to be; eSTAR is mandatory only for 510(k) and De Novo. The nIVD and IVD eSTAR templates carry PMA content, so the same template supports a voluntary PMA, a PMA panel-track supplement, or a 30-day notice.
- Substantial equivalence
- substantial equivalence is the scientific finding FDA makes about the device against a predicate. eSTAR is the form the supporting evidence is delivered in. A complete eSTAR says nothing about whether the predicate comparison will hold.
eSTAR obligations come from the two final guidances that implement section 745A(b) for devices, plus the operating rules on FDA's eSTAR Program page.
What you must do
- 1Prepare every 510(k) — Traditional, Special, and Abbreviated originals plus supplements and amendments — as an eSTAR electronic submission; a 510(k) not provided this way will not be received, and FDA does not intend to grant waiversElectronic Submission Template for Medical Device 510(k) Submissions, Section VI.B
- 2Prepare every De Novo classification request, supplement, and amendment as an eSTAR electronic submission for filings on or after October 1, 2025, the end of the one-year voluntary transitionElectronic Submission Template for Medical Device De Novo Requests, Section VI.B
- 3Use eSTAR for 510(k) and De Novo submissions to CBER as well as CDRH, and for combination-product and dual 510(k)/CLIA Waiver IVD filings, unless the submission falls in an exempted amendment categoryFDA eSTAR Program, Section A
- 4Confirm the header reads "eSTAR COMPLETE" before transmitting, and send 510(k) and De Novo eSTARs to CDRH through the CDRH Portal; the Portal will not accept an eSTAR still marked incomplete, and one mailed or sent via ESG while incomplete sits on hold for up to 180 daysFDA eSTAR Program, Section G
- 5Answer every dropdown and attachment question so it accurately describes the device, because FDA technical-screens within 15 days of receipt once the user fee is paid, and a failed screen holds the file until a complete replacement eSTAR arrivesElectronic Submission Template for Medical Device 510(k) Submissions, Section V
Common mistakes
Reading "eSTAR COMPLETE" as "submission ready"
the CDRH Portal verifies only that every applicable question has a response and at least one attachment. It does not read the attachments. FDA's technical screening does, and an attachment that does not belong to its question, or a dropdown answer that contradicts the device, puts the file on hold; miss the 180-day replacement window and FDA closes it as withdrawn.
Drafting the submission inside eSTAR instead of populating it
eSTAR is a dynamic PDF that does not support concurrent co-authoring, so only one person can edit at a time, and Adobe Acrobat Reader cannot save changes or add attachments at all. Teams that author predicate comparisons and test summaries in the template rather than finalizing them elsewhere lose weeks to file locking and version conflicts.
Ignoring template version retirement
FDA retires eSTAR versions on published dates (nIVD and IVD eSTAR 6.2 retire on August 3, 2026) and folds new policy into major versions, including the Human Factors content guidance published May 29, 2026 and effective August 1, 2026. Filing on a stale major version invites Additional Information requests on exactly the content that changed.
When This Matters
- The team pushed the finalized eSTAR to the CDRH Portal ahead of the user-fee deadline.
- Three attachment questions were still unanswered, so the template never flipped to eSTAR Complete.
- FDA is retiring the version we drafted in, so we exported the XML and imported it into eSTAR 7.0.
Frequently Asked Questions
No. A 510(k) is the premarket notification FDA reviews and clears; eSTAR is the interactive PDF template that notification has to be delivered in. FDA has required eSTAR for 510(k) submissions since October 1, 2023, so every current 510(k) is an eSTAR, but the template is only the container.
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