Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

Abstract as published in the Federal Register.

The comment window is still open until August 14, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.