FDA FINAL Guidance Benefit-Risk in Medical Devices

The US FDA issued a FINAL guidance entitled: “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions”. This defines FDA’s approach to evaluate the Risk-Benefit relationship when evaluating information about medical devices The guidance includes examples on how it applies this product availabilty (e.g., recalls and shortage) and also to compliance and enforcement decisions. It also includes a short Appendix on the relationship to ISO 14971 use of similar terms. The remaining appendices appear quite useful as checklists for things to consider and address in internal pre and post market risk evaluations and as a summary of the guidance.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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