FDA Consultation on the Electronic Submission Template for Investigational Device Exemption (IDE) Applications
On 28 October 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the electronic submission of Investigational Device Exemption (IDE) applications. The guidance outlines proposed requirements for using the electronic Submission Template And Resource (eSTAR) to standardize IDE submissions and improve regulatory review efficiency. Once finalized, the requirements would become mandatory for specified IDE submissions following a transition period of at least one year.
Overview
Authority | U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) |
Date | 28 October 2026 |
Focus | Standardized electronic submission requirements for IDE applications using eSTAR |
Type | Draft guidance for sponsors and FDA staff; request for comments |
Deadline for comments | 28 December 2026 |
What is this about?
Investigational Device Exemptions allow investigational medical devices to be used in clinical studies to collect safety and effectiveness data. Sponsors of certain clinical investigations, particularly those involving significant-risk devices, must obtain FDA approval of an IDE application before initiating the study.
The FDA is continuing its transition toward standardized electronic regulatory submissions. The proposed guidance supports implementation of Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which provides the statutory framework for electronic medical device submissions.
The guidance applies to IDE submissions handled by CDRH and CBER and proposes the use of eSTAR as the standardized electronic format for applicable submissions. The FDA already provides PreSTAR, a version of eSTAR that can be used voluntarily for IDE applications and certain other early regulatory submissions.
The proposal primarily concerns the format and preparation of regulatory submissions rather than introducing new substantive requirements for clinical investigations under 21 CFR Part 812.
This consultation complements the FDA's separate consultation on electronic submission templates for Premarket Approval (PMA) applications and certain PMA supplements, with a comment deadline of 17 November 2026. Both initiatives form part of the FDA's broader implementation of electronic submission requirements under Section 745A(b) of the FD&C Act, but address different submission types and have separate comment deadlines.
Related consultation: FDA Consultation on the Electronic Submission Template for Premarket Approval Applications (PMAs)
Consultation details
The draft guidance addresses several key aspects of the proposed electronic submission framework:
Submission scope: The requirements would apply to original IDE applications, IDE supplements and amendments to these applications. Certain other IDE-related submissions would remain exempt. Once the requirements become effective, applicable submissions that do not meet the prescribed electronic format would not be considered received by the FDA unless an exemption applies.
Standardized electronic format: Sponsors would use eSTAR, an interactive PDF-based template designed to guide submission preparation, organize supporting documentation and improve consistency with regulatory requirements.
Submission preparation and review: The structured template is intended to facilitate the preparation of complete submissions and enable FDA reviewers to locate and assess relevant information more efficiently.
Exemptions: The FDA proposes exemptions for interactive review responses, appeals or requests for supervisory review, withdrawal requests for IDE applications under review, and IDE reports and related amendments. Certain submissions involving compassionate use, emergency use and adverse event reporting are already exempt from mandatory electronic submission requirements.
Waivers: The FDA does not currently anticipate granting waivers from the proposed requirements, considering the electronic submission tools sufficiently accessible to sponsors.
Transition period: Mandatory use of eSTAR would begin no earlier than one year after publication of the final guidance. Sponsors may voluntarily use eSTAR before the requirements become effective.
The draft guidance distinguishes between recommendations and electronic submission requirements established under Section 745A(b) of the FD&C Act. Unlike ordinary guidance recommendations, certain electronic submission requirements, implementation timetables and exemption provisions established under this statutory authority may become legally binding once finalized and effective.
Useful links
Access the consultation materials and submission tools.
Official consultation information, supporting documents and comment deadline
Full draft guidance describing the proposed electronic submission requirements, exemptions and implementation approach
Official notice of availability, consultation details and instructions for submitting comments
Official docket for reviewing consultation materials and accessing the electronic comment submission process
Key timeline
Publication: 28 October 2026
Deadline for comments: 28 December 2026
Transition to mandatory electronic submission: At least one year after issuance of the final guidance
The FDA has not specified a date for publication of the final guidance.
Why this matters
The proposal represents another step in the FDA's transition toward standardized electronic submissions for medical devices. Although the underlying IDE regulatory requirements remain unchanged, mandatory use of eSTAR would establish new requirements for how sponsors prepare, organize and submit regulatory information.
For organizations conducting or planning clinical investigations in the United States, the transition may affect submission workflows, document management practices and regulatory operations. Sponsors may also need to assess how different IDE submission types fit within the proposed framework and whether any activities remain exempt from the requirements.
The consultation provides an opportunity to comment on practical implementation challenges, technical considerations and the adequacy of the proposed transition period before the final framework is adopted.
Who should consider responding?
Medical device manufacturers and sponsors submitting IDE applications to the FDA
Regulatory affairs professionals responsible for IDE preparation and lifecycle submissions
Regulatory operations teams managing electronic submissions and documentation
Clinical development teams involved in preparing investigational plans and supporting evidence
Industry associations representing medical device developers and clinical investigation sponsors
Practical implications
Stakeholders should consider:
Identifying current and planned IDE submissions that would fall within the proposed requirements
Reviewing existing submission preparation workflows against the eSTAR approach
Assessing potential technical, organizational and documentation-related challenges
Evaluating the proposed exemptions, waiver provisions and implementation arrangements
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