RegulatoryGuideline · draft

Forms FDA 3542a and FDA 3542: Questions and Answers

🇺🇸 FDA · Mon 15 Jun 2026

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

Official guideline text: FDA ↗

Brief written by VigiEye from the company's press release. Claims are the company's own. AI-assisted; check the source before acting.

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