Regulatory Deadline Board/2026-21953
Food and Drug Administration · Notice
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
60 days left
In plain English
FDA draft guidance introduces an electronic submission template for Investigational Device Exemption applications to CDRH and CBER.
Who it hits
IDE sponsors, clinical research orgs running device trials, and eSTAR or eCopy tooling vendors.
- Agency
- Food and Drug Administration
- Document type
- Notice
- Published
- Oct 28, 2026
- Comments close
- Dec 28, 2026
- Status
- 60 days left
- Federal Register number
- 2026-21953
- Docket
- Docket No. FDA-2026-D-11188
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