ARTICLE SUMMARY:
Efforts to capture subjective input, evaluate uncertainty, and feed the information into more statistically robust risk-benefit decision-making frameworks has been an important goal at FDA’s device center. Three documents recently issued by the agency nicely illustrate its current progress and thinking on the topic.
Adding more objectivity and quantification to the inherently squishy decision-making process needed to say whether the benefits of a device outweigh the risks for a particular patient population is a major goal at FDA.
