FDA GUIDANCE · DRAFTSeptember 18, 2026

Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff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, Premarket Approval (PMA)

Issue date

September 18, 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This is a draft guidance — issued for comment and not for implementation.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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