FDA GUIDANCE · FINALDecember 3, 2025

eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

What this record is not

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

Final

Topic

Premarket, User Fees, Administrative / Procedural, Investigational Device Exemption (IDE)

Issue date

December 3, 2025

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