Federal Register #2026-21953

FDA Draft Guidance on Electronic Submissions for IDE Applications

The FDA issued draft guidance on electronic submissions for Investigational Device Exemption applications; this is a guidance announcement, not a procurement opportunity. - Government buyer and offices: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), including the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). - Guidance scope: Electronic submissions for original IDE applications, supplemental applications, amendments, and related IDE submissions. - Purpose: Promote consistent preparation of submissions and support more efficient review; the guidance describes submission standards and implementation requirements. - Status and requirements: The guidance is a draft, is not final, and is not for implementation at this time. - Procurement details: No products, services, quantities, part numbers, OEMs, or vendors are requested.

Description

The FDA announces the availability of draft guidance titled “Electronic Submission Template for Investigational Device Exemption (IDE) Applications.” It introduces sponsors submitting IDE applications to CDRH and CBER to publicly available resources and content supporting electronic submissions, including original IDE applications, supplemental applications, amendments, and related submissions. The guidance is intended to support more consistent submissions and improve review efficiency, and when finalized will provide information on electronic submission standards and implementation. The draft guidance is not final and is not for implementation at this time; comments are due by December 28, 2026.

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