FDA Launches Regulatory Accelerator for Digital Health Devices

The U.S. Food and Drug Administration (FDA) has introduced a new initiative designed to streamline the development and approval of digital health devices. Overseen by the Center for Devices and Radiological Health (CDRH), the Regulatory Accelerator program is intended to give developers - particularly those creating software-based medical technologies - clearer guidance and easier access to resources throughout the innovation process.

Through the program, developers can explore a Resource Index, which serves as a visual guide to tools, guidance documents, and engagement opportunities such as webinars, helping innovators navigate every stage of device development and the regulatory review pathway. The initiative also offers Orientation Meetings, where FDA staff provide an overview of the submission process and additional information to support developers as they prepare for market approval. In addition, the Medical Device Software Guidance Navigator helps innovators identify which FDA guidances apply to their specific digital health product and explains how those guidances align with the agency’s electronic Submission Template and Resource (eSTAR) system.

The FDA said the goal of the Regulatory Accelerator is to give new and emerging developers a clearer understanding of regulatory expectations, reduce barriers to entry, and promote a more efficient review of device submissions. By simplifying access to regulatory resources and offering direct engagement opportunities, the initiative is expected to help innovators bring safe, effective, and cutting-edge digital health devices to market more quickly, ultimately expanding patient access to new technologies.