The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The cybersecurity framework, typically seen in other industries such as defense contracting, serves as a warning to companies in the life sciences, medtech, and digital health space that DOJ and the whistleblower bar are expanding the scope of this flavor of FCA enforcement and should prepare accordingly.
As Prescribed
YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an overview of FDA’s approach to predetermined change control plans (PCCPs) and its draft guidance on pre-market submission requirements for AI-enabled devices, a summary of current trends in devices enabled with artificial intelligence (AI) or authorized with PCCPs, as well as the burgeoning global adoption of PCCPs.