The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (FDA’s CDRH) and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have established stringent regulatory requirements to ensure the cybersecurity of medical devices. The FDA’s CDRH mandates evidence of a comprehensive vulnerability monitoring and management program, a total product lifecycle approach to device security, and the provision of a machine-readable Software Bill of Materials (SBOM). Additionally, the FDA retains the authority to impose further requirements as deemed necessary by the Secretary of Health and Human Services (HHS) through regulation. Detailed guidance on these requirements is outlined in the 2023 Final Premarket Guidance, the 2024 Draft Select Updates for the Premarket Guidance, and the 2016 Postmarket Guidance.
This is the third presentation from day 2 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy or fill out the form on this page for access.