On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.
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The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED).
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under Section 524B of the Federal Food, Drug, and Cosmetic Act (FFDCA). These new statutory cybersecurity requirements, enacted in December 2022 as part of the Food and Drug Omnibus Reform Act (FDORA), are starting to take centerstage as the medical device sector begins to address new enforcement risks for cybersecurity deficiencies under more traditional fraud and abuse laws, such as the False Claims Act (FCA).
With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of more than 100 “cease and desist” letters, the agency has demonstrated it believes that DTC marketing of prescription drugs may have gone too far and that it is committed to bringing the industry back into regulatory compliance.
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.
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.