FDA Drafts Guidance Requiring eSTAR Template for IDE Applications

The US Food and Drug Administration has issued draft guidance that would require sponsors to file investigational device exemption (IDE) applications electronically using its eSTAR template. As Regulatory Focus reported, the eSTAR template is already required for 510(k), De Novo and related submissions.

The draft, titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications," was announced in a Federal Register notice published October 28. It covers IDE applications submitted to the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

Required after a transition

According to the draft guidance, once it is finalized, all IDE applications not otherwise exempt "will be required to be submitted as electronic submissions as of the implementation date." An application not provided electronically as of that date "will not be considered received" unless an exemption applies, the draft says.

The FDA said it intends to provide "a transition period of a minimum of one year from the final guidance issuance" before requiring electronic IDE submissions. In the meantime, sponsors may use eSTAR voluntarily. Submissions to CDRH must go through the FDA's electronic portal, while CBER submissions go through its Electronic Submissions Gateway, the draft says.

The agency describes eSTAR, short for electronic Submission Template And Resource, as a template of questions, logic and prompts that guides a sponsor through building an IDE application covering the elements required under 21 CFR Part 812. CDRH first piloted eSTAR in February 2020, according to the draft.

Exemptions and no waivers

In the final guidance, the FDA intends to exempt four kinds of IDE submissions from the electronic requirement: interactive review responses, appeals and requests for supervisory review, withdrawal requests for applications under review, and IDE reports and related amendments. Expanded access, emergency use and adverse event reports are already exempt under earlier guidance.

The agency does not plan to grant waivers. "At this time, FDA has not identified any particular circumstances appropriate for a waiver of the IDE electronic submission requirements and does not intend to grant requests for waiver," the draft states, citing the wide availability of software that can open the eSTAR PDF.

The draft also restates that the FDA intends to review and reach a decision on every IDE electronic submission within 30 days of receipt.

Legal basis and comments

The FDA said the guidance, when finalized, will help implement section 745A(b) of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Reauthorization Act of 2017, which lets the agency specify electronic submission standards, a timetable and criteria for waivers and exemptions in guidance. To the extent it sets such requirements, the Federal Register notice says, the document is not subject to the usual rule that guidance does not create legally enforceable responsibilities.

The draft also cites the agency's commitments under the 2017 and 2022 medical device user fee agreements to develop electronic submission templates. Comments on the draft are due by December 28, 2026.