Reimagining the FDA ’s Role in Digital Medicine

In addition to evaluating the safety of software as a medical device (SaMD), the agency needs to devote more resources to evaluating its efficacy and quality.John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article.The FDA ’s approach to software as a medical device (SaMD) has been evolving. Consider a few examples.In 2018, IDx-DR, a software system used to improve screening for retinopathy, a common complication of diabetes that affects the eye, became the first AI-based medical device to receiveUS Food and Drug Administration clearance to “detect greater than a mild level of … diabetic retinopathy in adults who have diabetes.” To arrive at that decision, the agency not only reviewed data to establish its safety, it also took into account prospective studies, an essential form of evidence that clinicians look for when trying to decide if a device or product is worth using. The software was the first medical device approved by the FDA that does not require the services of a specialist to interpret the results, making it a useful tool for health care providers who may not normally be involved in eye care. The FDA clearance e mphasized the fact that IDx-DR is a screening tool not a diagnostic tool, stating that patients with positive results should be referred to an eye care professional. The algorithm built into the IDx-DR system is intended to be used with the...
Source: Life as a Healthcare CIO - Category: Information Technology Source Type: blogs