The Medical Device Amendments to the Food, Drug, and Cosmetics Act mandates that substantially new devices be subjected to study and testing prior to the commencement of clinical trials. The proposed outline for preclinical analysis, testing, and evaluation of orthopaedic implants is intended to guide the designer in defining what the limits of understanding are and, within those limits, to minimize the risk to implant recipient. The process of design qualification and verification is broken down into seven major steps: Problem Definition, Underlying Assumptions, Material Selection, Engineering Analysis, Correlation of Demand to Capabilities, Analytical Estimate of Performance and Experimental Verification of Performance. The discussion of each of these topics focuses on the type of information needed for each activity. Thus, these guidelines present a framework for the rational innovation and design of orthopaedic implants which minimizes the risk to patients involved in clinical trials.

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