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The CDRH and CBER just issued a draft guidance titled Electronic Submission Template for Investigational Device Exemption (IDE) Applications. It’s the agency’s first draft guidance on using eSTAR (the FDA’s Electronic Submission Template and Resource) for IDEs.
Device sponsors may recognize a pattern emerging here. eSTAR has been required for 510(k)s since October 1, 2023 and for De Novo requests since October 1, 2025, and FDA issued a similar draft for PMAs in September. Today, sponsors can voluntarily use FDA’s PreSTAR eSTAR for original IDE applications, IDE supplements and amendments to those submissions. The current template is not intended for IDE Reports. This draft lays the groundwork for making it required in the future.
It’s a Level 1 draft guidance, marked “Not for Implementation,” so none of the proposed IDE eSTAR requirements are in effect yet. Existing statutory and Part 812 requirements cited in the document still apply. Comments are due December 28, 2026, under docket FDA-2026-D-11188.
A lot of FDA guidance is nonbinding, but this one won’t be entirely. Section 745A(b)(3) of the FD&C Act expressly authorizes FDA to establish electronic-submission standards, an implementation timetable, and criteria for waivers and exemptions through guidance. Once final, those provisions will have binding effect.
Outside those provisions, the guidance’s own recommendations are nonbinding. But the document also cites and summarizes requirements that already exist in statutes and regulations, particularly 21 CFR part 812. So just to be very clear, not every mandatory obligation discussed here originates with this guidance. The FDA uses words such as must and required for requirements and should for recommendations.
Let’s break this draft down to look at what the FDA is setting up.
What counts as an "IDE application"
The draft uses a pretty broad definition. “IDE applications” collectively means:
Original IDE applications (21 CFR 812.20)
IDE supplemental applications (21 CFR 812.35)
Amendments to original IDE applications and to IDE supplemental applications
Related IDE submissions
The requirement here, according to this draft, would apply to IDE applications not otherwise exempted. The exemptions are covered below, and the draft’s own example is that IDE reports and amendments to IDE reports are exempt.
The practical point we’re seeing here is that this isn’t only about the original IDE. Supplements and amendments over the life of a study would be in scope too.
What happens if and once it’s required
Section VI states it directly: Upon finalization, all IDE applications, unless exempt, will be required to be submitted as electronic submissions as of the implementation date. An IDE application that isn’t provided as an electronic submission as of that date “will not be considered received” unless an exemption applies.
For CDRH, the draft says the electronic submission must be submitted through FDA’s electronic portal. For CBER, it points sponsors to the Electronic Submissions Gateway.
When it would take effect
No date exists yet. The draft says the final guidance will specify the timetable, and that FDA intends to provide a transition period of at least one year from issuance of the final guidance before requiring IDE applications to be electronic submissions.
Until then, eSTAR remains voluntary for IDEs.
What would stay exempt
In the final guidance, FDA says it intends to exempt four IDE submission types from the electronic submission requirement:
Interactive review responses. If the reviewer used interactive review by phone or email, the sponsor should reply to the reviewer by email with the requested attachments and information. Other responses to requests for additional information must go through eSTAR once the guidance is final and the implementation date has passed.
Appeals and requests for supervisory review. These remain subject to any applicable eCopy requirements. The draft notes that FDA has authority to require an electronic format for appeals too, and intends to update the guidance if it develops one.
Withdrawal requests for IDE applications currently under review.
IDE reports and related amendments. These also remain subject to any applicable eCopy requirements.
The draft also notes that some IDE submissions are already exempt from submission solely in electronic format under FDA’s 745A(b) device parent guidance:
Expanded access compassionate use requests and reports
Emergency use reports
Adverse event reports of all types
The FDA is still encouraging electronic formats for these where available.
It’s important to note that eCopy is not the same thing as eSTAR. The draft defines an eCopy as an electronic duplicate of what used to be a paper submission, and says plainly that an eCopy is not considered an electronic submission. Exempt items that remain subject to eCopy requirements still have to meet those requirements.
The FDA is proposing no waiver path
The FDA says it hasn’t identified any circumstances appropriate for a waiver of the IDE electronic submission requirement and doesn’t intend to grant waiver requests. Its reasoning is that the eSTAR PDF is free to download from FDA’s website and software to use it is widely available, so all sponsors should be able to submit one.
The only accommodation the draft describes is for known technical problems that prevent submission through the CDRH Portal. Those submissions should be mailed to the CDRH Document Control Center. (That’s a different delivery route, not an exemption from eSTAR.)
What the template asks for
Let’s get into the template itself.