FDA Proposes Guidelines to Clarify Benefit-Risk Determinations for Medical Devices

• By: Staff Editor
• Date: August 18, 2011

The FDA has for the first time issued a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily. The agency is presently accepting comments on these draft guidelines.

This article provides a summary of the guidance document’s recommendations.