FDA · Basic · 12 min lesson
What eSTAR is - the template, who must use it, and how it reaches FDA
FD&C Act section 745A(b), FDA 510(k) and De Novo eSTAR guidances, FDA eSTAR program page, CDRH Portal
What you will learn
- Explain what eSTAR is, which FDA submissions must use it, which may use it voluntarily, and why.
- Describe how eSTAR replaced paper and eCopy for 510(k) and De Novo and which route carries it to FDA.
- Explain technical screening and the hold, and prepare a controlled planning record before opening the form.
Key takeaways
- eSTAR is FDA's interactive PDF template: required for 510(k) since 1 October 2023 and De Novo since October 2025.
- PMA, pre-submission, IDE and 513(g) uses are voluntary; the statutory basis is FD&C Act section 745A(b) with guidance.
- CDRH submissions go through the CDRH Portal; CBER uses the gateway; an incomplete eSTAR is refused.
- Technical screening can hold a submission up to 180 days; with no replacement it is treated as withdrawn.
- Keep a controlled planning record: pathway, template version and date, route, owner, backup and hold plan.
Free practice question
Halden finishes a 510(k) for a wearable ECG patch in March 2026 as a 140 page PDF built in a word processor, with the same headings as the FDA template. The regulatory lead asks if it can be uploaded to the CDRH Portal as it is.
What is the correct response?
Upload it; matching headings satisfy the requirement.
Not quite. FDA guidance requires the eSTAR template itself for 510(k), so matching headings do not meet the section 745A(b) requirement.
Re-enter the content in the current non-IVD eSTAR and upload that.
Correct. Since 1 October 2023 FDA guidance requires 510(k) electronic submissions in eSTAR, so the content must go into the template. Reference: FDA eSTAR program page, section on scope and submission.
Send it by email to the reviewing division.
Not quite. Email is not the CDRH route; the Portal is, and the template is still required under the 2023 guidance section on format.
Mail a paper copy with an eCopy disk.
Not quite. The paper plus eCopy route was replaced for 510(k) submissions by the eSTAR requirement of FD&C Act section 745A(b) guidance.
Key terms
- eSTAR: electronic Submission Template And Resource: FDA's interactive PDF form for preparing device submissions.
- CDRH Portal: The online system through which CDRH receives 510(k) and De Novo submissions and other premarket files.
- eCopy: The earlier program in which an electronic copy of a paper submission was sent in a prescribed structure.
- technical screening: FDA check of an uploaded eSTAR for virus, relevance of attachments and accuracy of answers; can lead to a hold.
- hold: A pause of up to 180 days for the applicant to send a replacement; with none the submission is considered withdrawn.
- De Novo: Classification request for a novel low to moderate risk device with no predicate (FD&C Act section 513(f)(2)).
Official sources
- FDA, eSTAR Program
- FDA guidance, Electronic Submission Template for Medical Device 510(k) Submissions
- FDA guidance, Electronic Submission Template for Medical Device De Novo Requests
- FDA, Send and Track Medical Device Premarket Submissions Online: CDRH Portal
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.