Module 15 Presentations

15/04/2024

How do I communicate the benefits and risks of the device to FDA to support clinical data and approval?

The Organisation for Professionals in Regulatory Affairs

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FDA Guidance Helps Clinical Strategic Thinking: Framing Benefits versus Risks

1. Published guidance that provides benefit-risk assessment checklists important for clinical assessments 2. Mainly focused on supporting a De Novo /510(k) submission (novel low to moderate risk device) 3. Benefits: 1. Type of benefit 2. Magnitude of benefit 3. Probability of patient experiencing a benefit 4. Duration of effect 4. Risks: 1. Device-related, procedure-related 2. Probability of harm 3. Duration of harmful event

https://www.fda.gov/media/99769/download

The Organisation for Professionals in Regulatory Affairs

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