← FDA GUIDANCE
FDA GUIDANCE · DRAFTOctober 28, 2026
Electronic Submission Template for Investigational Device Exemption (IDE) Applications: Draft Guidance for Sponsors and Food and Drug Administration Staff
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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.
Status
Draft
Topic
Electronic Submissions, Investigational Device Exemption (IDE)
Issue date
October 28, 2026
This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.
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