Guidance on Device Benefit-Risk Decisions

FDA has posted a final guidance on “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” that outlines the principal factors it considers when making such determinations during the premarket review process for certain medical devices. The document is intended to improve the predictability, consistency, and transparency of the premarket review process.

The guidance includes a worksheet that reviewers will use in making benefit-risk determinations, and there are examples of how reviewers might use the worksheet. “By documenting reviewers’ thought processes as part of the administrative record and, in certain cases, the publicly available summary of our decision, sponsors will have a better idea of the basis for FDA’s favorable decisions and gain a greater understanding of what factors were considered as part of an approval or a down-classification decision through the de novo process,” it says.