FDA drafts guidance on submitting IDEs via eSTAR ahead of transition
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption (IDE) applications electronically using the electronic Submission Template and Resource (eSTAR) template.
Once the guidance is finalized, FDA said it will require sponsors to submit using eSTAR following a transition period of at least one year, though sponsors may submit IDE applications using eSTAR voluntarily before then.
The eSTAR template is already required for all 510(k) submissions and De Novo submissions, including those for combination products, dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) waivers for in vitro diagnostic (IVD) submissions. The guidance applies to IDE submissions to both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
FDA stated in the draft guidance that the final version will set further standards for electronic submissions, a timetable for establishing these standards, and criteria for waivers and exemptions from the requirements.
The agency said the final guidance will exempt four IDE submission types from electronic submission requirements: Interactive review responses, appeals and requests for supervisory review, withdrawal requests of IDE applications currently under review by FDA, and IDE reports and related amendments.
Certain IDE submissions are already exempt from the requirement to submit in electronic format, FDA said. These exemptions include requests for expanded access compassionate use, emergency use reports, and adverse event reports.
However, for all other requests, the FDA has indicated that it has not identified any specific circumstances that would warrant a waiver of the IDE electronic submission requirements and does not intend to grant any waiver requests. The agency noted that since the current IDE format is available at no cost, all sponsors should be able to provide an IDE eSTAR.
The guidance outlines the structure of the eSTAR IDE electronic submission template. This template should be used to transmit the application or submission type, designation of the IDE application as either an original IDE application or a supplemental IDE application, a cover letter and letters of reference, and any pre-submission correspondence and the consensus standards used to develop the product.
Furthermore, the template should be used to transmit general clinical information, a product description, intended product use, information on sterility and shelf life, as well as informed consent forms.
FDA announced in February 2020 it would pilot the interactive, PDF-based 510(k) eSTAR template as the next step in transitioning to 510(k) submissions based on an electronic format. (RELATED: FDA to Pilot Interactive 510(k) Template, Regulatory Focus 26 February 2020)
The agency said it plans to review electronic IDE submissions within 30 days of receiving the application.
Stakeholders can comment on the guidance on www.regulations.gov under docket no. FDA-2026-D-11188 until 28 December.
