2019 - What To Expect From FDA’s New Approach to Regulate Medical Software

FDA’s history in regulating medical software
Evolution of FDA’s regulatory framework
21st Century Cures Act clarifies FDA jurisdiction
Software functions excluded from medical device oversight
Medical software as a medical device (SaMD) and software in a medical device (SiMD)
Overview of FDA’s Digital Health Innovation Action Plan
FDA’s Software Recertification Program and 2019 Test Plan
Summary of FDA’s new regulatory framework
Role of stakeholders in FDA’s revised
What are the FDA’s next steps
Key questions about FDA’s streamlined regulatory approach
Implications for health software industry