FDA draft would require IDE applications for device trials to come in through eSTAR

Sponsors who need FDA approval to run a significant risk device study would have to file that application as an electronic submission after a transition that follows the final guidance, under a draft guidance the FDA announced in its October 28, 2026 notice. The only template that produces one today is eSTAR, the draft says. It names no grounds for a waiver, and the transition lasts a minimum of one year from the final guidance. For an investigator who sponsors a device study, the original application, its supplements and amendments, and formal answers to FDA requests for more information would all move into that template.

Why it matters

Today a valid eCopy is required for original IDE applications and most IDE supplements, amendments and reports, the FDA's IDE application page says. eSTAR is on the FDA's list of voluntary use for IDEs, while premarket notification (510(k)) and De Novo submissions already must use it, unless exempted, according to the FDA's eSTAR program page. Section 745A(b) of the Federal Food, Drug, and Cosmetic Act lets the FDA require electronic submissions from a date it sets in final guidance, the draft explains. Guidances ordinarily are recommendations only, but insofar as this one sets standards, a timetable and criteria for waivers and exemptions, "it will have a binding effect when final," the draft says.

What the template asks for

The draft describes eSTAR as "a structured dynamic PDF that guides a user through construction of an eSubmission." It is built to follow the content of the SMART IDE review memo template, an internal review tool used by FDA reviewers, and it prompts for documents based on earlier answers. When software is indicated, for example, eSTAR asks for the software documentation.

The template's sections, as the draft lists them, include:

general clinical information: the type of study, such as early feasibility or feasibility; confirmation that the study is a significant risk device study; and whether the study is a sponsor or sponsor-investigator led study;
the investigational plan, or an accurate summary of its sections, and a description of the records and reports the investigation will keep;
all forms and informational materials to be provided to subjects as part of the informed consent process;
information related to investigational sites and investigators;
labeling, manufacturing information, and reports of prior investigations, including all prior non-clinical and clinical testing;
an amendment and additional information response section for answers to disapproval or approval with conditions decision letters.

The FDA intends to review and reach a decision on every IDE electronic submission within 30 days from the date of receipt, the draft says.

What stays outside the template

In the final guidance, the FDA intends to exempt four kinds of IDE submissions from the requirement:

interactive review responses;
appeals and requests for supervisory review;
withdrawal requests of IDE applications currently under review;
IDE reports and related amendments.

Expanded access compassionate use requests and reports, emergency use reports, and adverse event reports of all types are already exempt from submission solely in electronic format, the draft says. IDE reports and appeals remain subject to any applicable eCopy requirements.

Answers to FDA questions split two ways. If a reviewer used interactive review by phone or email, the sponsor replies by email. Other responses to requests for additional information "must be submitted in eSTAR" once the guidance is final and the implementation date has passed.

No waivers, and at least a year to switch

The FDA "has not identified any particular circumstances appropriate for a waiver" and "does not intend to grant requests for waiver," the draft says, because software to use the eSTAR PDF is widely available. After the implementation date, an IDE application that is not an electronic submission "will not be considered received" unless an exemption applies.

The current template for IDEs is the Early Submission Requests eSTAR, called PreSTAR, version 3.1 on the eSTAR program page. It covers Original IDEs and Supplements, as well as their Amendments, but not IDE Reports. Until the requirement starts, its use is voluntary, and submissions to CDRH go through the FDA's electronic portal.

Who files these applications

Clinical evaluation of a device that has not been cleared for marketing requires an investigational plan approved by an institutional review board, and when the study involves a significant risk device, the IDE must also be approved by FDA, the FDA's IDE overview says. A sponsor of a significant risk device study must submit a complete IDE application, the IDE application page says. When one individual both initiates and conducts the study, that person is a sponsor-investigator, whose obligations include those of an investigator and those of a sponsor, the FDA's IDE definitions page says.

ClinicalTrials.gov shows how many recruiting studies involve an FDA-regulated device. When this analysis was prepared, its records listed:

3,932 recruiting studies that study a U.S. FDA-regulated device product (registry query);
986 of those studying a device product not approved or cleared by the FDA (registry query);
486 of the 986 with an industry lead sponsor (registry query);
75 of the 986 that name a sponsor-investigator as the responsible party (registry query).

These registry fields do not record whether a study holds an IDE, so the counts show the pool of studies, not the number of IDE applications. In a sponsor-investigator study that needs an IDE, the sponsor's filing duties sit with the same individual who conducts the study.

Dates to know

October 28, 2026: the draft guidance and its Federal Register notice, docket FDA-2026-D-11188.
December 28, 2026: comments due so the FDA considers them before it begins work on the final version, through regulations.gov or in writing to the Dockets Management Staff.
The final guidance, then a transition of a minimum of one year before IDE applications must be electronic submissions.

What remains uncertain

The implementation date is not set. The draft says the final guidance is where the FDA specifies the timetable for IDE electronic submissions (FDA draft guidance). For IDE appeals, the draft says the FDA intends to update the guidance once it develops an electronic format for them.