USFDA Draft Guidance: Electronic Submission Template for Investigational Device Exemption (IDE) Applications
The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Electronic Submission Template for Investigational Device Exemption (IDE) Applications” to support sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
The October 2026 draft guidance introduces the electronic Submission Template and Resource (eSTAR) as the current electronic submission template for IDE applications. It describes the proposed electronic submission standards, template structure, exemptions, waivers, and implementation timeline. The initiative aims to improve submission consistency and enhance efficiency in the FDA review process.
Scope of the Draft Guidance
The guidance describes the technical standards associated with preparing electronic IDE submissions. The eSTAR template includes information and guided prompts designed to help sponsors collect and assemble the elements of an IDE application required under 21 CFR Part 812.
The document focuses on the electronic submission format and standards rather than specifying the detailed user interface or content of eSTAR. FDA also intends to implement new versions of eSTAR as relevant policies change and continues to collect stakeholder feedback.
eSTAR: A structured, dynamic PDF-based electronic submission template that guides users through the preparation of an electronic submission. It is currently the only available electronic submission template for IDE applications.
Structured Data: Information captured through fields, dropdown boxes, checkboxes, and other template components.
Unstructured Data: Information submitted as attachments to the electronic submission template.
Structure and Content of the IDE eSTAR Template
The current IDE eSTAR template contains questions, text, logic, and prompts designed to guide sponsors through the preparation of an IDE application. It includes automated features, integrated databases, references to FDA-recognized voluntary consensus standards, and links to relevant regulations, guidances, and other resources.
The template is structured around the following information categories:
Application and Submission Type: Identification of the submission as an Original IDE Application, IDE Supplemental Application, or Additional Information Response.
Cover Letter and Letters of Reference: Cover letters and documents referring to other submissions.
Sponsor Information: Details of the sponsor and correspondent, where applicable.
Previous Regulatory Interactions: Information about prior or ongoing submissions for the same device, including relevant submission numbers and regulatory interactions.
Consensus Standards: Identification of applicable FDA-recognized and non-recognized voluntary consensus standards.
General Clinical Information: Study type, study objectives, US study involvement, significant-risk status, informed consent considerations, and other clinical study details.
Product Description and Intended Use: Device characteristics, materials, design, energy source, operating principles, proposed conditions of use, accessories, and intended use.
Report of Prior Investigations: Complete reports of prior nonclinical and clinical testing.
Reprocessing, Sterility and Shelf Life: Relevant validation information and supporting data, where applicable.
Biocompatibility: Assessment of patient-contacting materials, where applicable.
Software, Firmware and Cybersecurity: Applicable software documentation, cybersecurity assessments and interoperability information.
Electromagnetic Compatibility and Safety: EMC, electrical, mechanical, wireless and thermal safety testing information, or a justification where testing is not needed.
Investigational Plan: The complete investigational plan or an accurate summary of the required sections, including records and reports to be maintained.
Informed Consent: Forms and information materials provided to study participants.
Investigational Sites and Investigators: Information about study sites and investigators.
Labelling and Manufacturing Information: Proposed device labelling and details of manufacturing methods, facilities and controls.
References and Administrative Documentation: Relevant literature, administrative forms and a recommended submission or executive summary.
Amendments and Additional Information Responses: Amendments and responses to deficiencies or issues identified in FDA IDE decision letters.
Sponsors may also include relevant supporting attachments, such as documents, PDFs, images, and videos. The template may automatically prompt for additional documentation based on device characteristics and sponsor responses. For example, indicating that software is used will trigger a prompt for applicable software documentation.
FDA Review Timeline
FDA intends to review and reach a decision on every IDE electronic submission within 30 days from the date of receipt.
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For IDE applications involving an exception from informed consent under 21 CFR 50.24, FDA will provide a written determination within 30 days. Such clinical investigations cannot proceed without prior written FDA authorization. The draft guidance also explains that eSTAR content is structured to closely follow the Submission Memo and Review Template (SMART), an internal review tool used by FDA reviewers.
Waivers and Exemptions from Electronic Submission Requirements
Once the draft guidance is finalized and the implementation date arrives, IDE applications will generally require electronic submission unless an exemption applies.
FDA intends to exempt the following submission types:
Interactive review responses.
Appeals and requests for supervisory review.
Withdrawal requests for IDE applications currently under FDA review.
IDE reports and related amendments.
Certain submissions are already exempt from the requirement to be submitted solely in electronic format under the existing 745A(b) device parent guidance. These include expanded access compassionate use requests, emergency use reports and adverse event reports, including serious adverse events and malfunction reports. FDA nevertheless encourages their submission in available electronic formats to facilitate review.
At this time, FDA has not identified particular circumstances appropriate for waivers and does not intend to grant waiver requests for IDE electronic submission requirements.
Implementation Timeline and Submission Process
The electronic submission requirements will become applicable after the draft guidance is finalized and the specified implementation date is reached.
FDA intends to provide a minimum one-year transition period following issuance of the final guidance before IDE applications must be submitted electronically.
During the transition period, sponsors may voluntarily use eSTAR for IDE applications.
For submissions to CDRH, the electronic submission must be provided through FDA's electronic portal. For CBER-regulated submissions, sponsors should refer to the applicable electronic submission instructions and submit through the Electronic Submissions Gateway.
The draft guidance also provides contact details for sponsors requiring support with electronic submission preparation:
Public Comments and Draft Guidance Status
The document was issued on October 28, 2026, and is being distributed for public comment. FDA requests comments and suggestions within 60 days of publication of the notice of availability in the Federal Register.
The FDA webpage specifies December 28, 2026, as the comment submission deadline. Comments can be submitted electronically through Regulations.gov or in writing to the FDA Dockets Management Staff, identifying docket number FDA-2026-D-11188.
As this is a draft guidance marked “Not for Implementation,” sponsors should distinguish the proposed electronic submission requirements and implementation timeline from requirements that are already in effect.
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