The U.S. Food and Drug Administration (FDA) has published two final guidance documents related to benefit-risk determinations in medical device premarket approvals, de novo classifications and humanitarian device exemptions.
Issued in late-August, the first Guidance, entitled “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” is intended to provide the industry with information on the factors the FDA considers when making benefit-risk determinations during the premarket review process for diagnostic and therapeutic medical devices. This Guidance also addresses the “Intersection” of the information found in the Guidance with the requirements of ISO 14971, Medical devices – Application of risk management to medical devices.
The second Guidance, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions,” was also issued in late August and specifically addresses the issue of uncertainty in assessing the safety and effectiveness of a given device, including whether the probable benefits of device use outweigh probable risks.
Guidances issued by the FDA are intended solely to provide insight into the agency’s current thinking on a given topic and do not have the force of law. However, the information they contain can be extremely helpful to medical device manufacturers in preparing complete and accurate device submissions for FDA review.
Read the FDA’s Final Guidance on Benefit-Risk Determinations.
Read the FDA’s Final Guidance on Uncertainty in Benefit-Risk Determinations.
