Module 15 2022

19/05/2022

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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Guidance that help clinical strategic thinking: Framing benefits/risks

1. Published guidance that provides benefit-risk assessment checklists important for clinical assessments 2. Mainly focused on supporting a de novo 510k 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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