Quick Tip - Use FDA guidance and worksheet for benefit-risk evaluation

Benefit-risk evaluation of a medical device often proves to be challenging in practice. Here is a practical approach and a case study you can apply in your risk management process.

Medical device manufacturers must prove their devices are safe and effective before they are granted marketing authorization by regulatory authorities.

According to FDA regulations, manufacturers must provide sufficient scientific evidence to show that probable benefits of their devices outweigh probable risks when used according to instructions within the scope of the approved intended use.

This exercise proves to be quite challenging in practice.

One reason is that there are no benchmarks or standardized quantitative models for evaluating benefit-risk of medical devices. As a result, this exercise involve a considerable amount of uncertainty and judgment, and the final output is often vague and prone to bias.

There continues to be a need to treat medical device benefit-risk determinations in a more structured way.

So, if you are struggling with benefit-risk evaluations, you are not alone!

The good news is that FDA has published a structured approach for benefit-risk in a guidance document¹. This guidance offers a benefit-risk worksheet, as shown below, where each section can be completed based on answers to a set of questions.

Recently, I gave a presentation on this topic at the International Conference on Medical Device Safety Risk Management, held in Amsterdam. Using a case study, I illustrated how a semi-quantitative approach could be applied to summarize the benefit-risk evaluation in a more structured way.

Paid subscribers of Let’s Talk Risk! newsletter can get a PDF of my slides below.

In the absence of a generally accepted standard, applying the FDA guidance for benefit-risk offers a pragmatic approach to risk practitioners.