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David Giese

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05:00
2026-08-29
innolitics.com
ai-policy

FDA Pre-Subs: Best Practices, FAQs, and Examples

Innolitics partner David Giese, who has helped bring 35+ AI-enabled diagnostic devices to the US market, published a guide on FDA Pre-Submissions, noting that the FDA currently charges no fee for Pre-…

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Innolitics 1 FDA 1 MDUFA VI 1 PreSTAR 1
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