September 26, 2019

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions”

Philadelphia associate Katherine McBeth and partner Chanda Miller, along with Florham Park partner and co-chair of the Products Liability and Mass Tort Group and the Pharma and Life Sciences Group Michael C. Zogby, co-authored a Drinker Biddle on Products blog post titled “FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.”

In the post, they provide information on the FDA’s recent Final Guidance and how the FDA evaluates uncertainty and the appropriate extent of uncertainty in the benefit-risk determination for medical devices that are subject to premarket approval.

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