FDA releases draft guidance on electronic IDE submission template
Comments on the draft guidance are due by December 28, 2026. The guidance targets sponsors filing IDE applications with the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.
Primary source
Federal Register notice, October 28, 2026
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
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