6 FDA Software Exemption Guidances Analyzed
Akin Gump attorneys have analyzed a revised FDA clinical decision support (CDS) draft guidance and summarized noteworthy changes in five additional guidances included in a package recently released by the agency to further clarify its interpretation of the 21st Century Cures Act’s software exemptions. The attorneys write that the revised CDS guidance “further elaborates on how to make CDS tools appropriately transparent for healthcare professionals such that they are not regulated as medical devices. It also introduces a risk-based framework for regulating CDS software that is a medical device, based on criteria adopted by the International Medical Device Regulators Forum.”
The five finalized guidances and revised draft provide stakeholders with additional clarity on which software-based applications and features are within the scope of the Cures Act exemptions or will otherwise be subject to FDA enforcement discretion, the attorneys write.