FDA Finalizes Post-Market Benefit-Risk Guidance

The guidance document attempts to help manufacturers and the agency consistently apply benefit-risk factors in making decisions about non-conforming products on the market and regulatory compliance issues. It is part of FDA’s larger effort to harmonize risk-benefit standards throughout the agency’s device center.

Industry may want to use a newly final benefit-risk guidance document from US FDA to guide recall decisions, the agency said in the Dec. 27 document.

The guidance, which is part of an ongoing effort to harmonize benefit-risk considerations throughout the FDA’s device center, proposes a...

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