TAG ARCHIVES FOR medical devices


Since I started working for our IRB in 2010, we have seen an increase of studies using software and medical apps. The uses of the software vary greatly and involve using software to monitor sleep, physical activity, diet diary, mental health among many other uses. This makes the application of device regulation quite confusing, and discussion, with case examples, among IRB professionals can be incredibly useful in exploring how best to apply the regulations and guidance. Read more


In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more