Acceptance Review for De Novo Classification Requests: Final Guidance

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U.S Food & Drug Administration
Wednesday, September 18, 2019 | 11am EDT (US and Canada) / 11pm CST (China) / 4pm BST (UK) Long > 60 min | English

Webinar Details

This webinar provides final guidance on the FDA’s Medical Device User Fee Amendments (MDUFA IV). It provides clarity about the De Novo pathway and explains how the FDA will evaluate De Novo classification requests to see if they meet the minimum threshold of acceptability. This guidance includes a De Novo Acceptance Checklist and a Recommended Content Checklist to help device manufacturers.

We hope this clarity will provide predictability and consistency for industry when preparing submissions, and enhance patient access to new, safe, and effective medical devices.

A transcript and slides are also available.

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Webinar Type: Recorded

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