Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions" (uncertainty guidance) in tandem with an updated version of the final guidance "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications" originally released in August 2016 (benefit-risk guidance).

Taken together, these two guidances seek to provide greater clarity for addressing the acceptable degree of clinical "uncertainty" about a medical device's safety and effectiveness in moving innovative products to market quickly to meet patient needs while also protecting public health from potentially unsafe products. Notably, although the final uncertainty guidance did not differ materially from the draft guidance issued in September 2018, the updated benefit-risk guidance features a completely new worksheet for benefit-risk assessment. The new worksheet follows a decision-tree format (rather than the prior table format) and includes new questions and a sequential method for considering benefit-risk and how to mitigate risks.

Read More: Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance


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