The U.S. Food and Drug Administration (FDA) has announced a new initiative to support the more efficient development of digital health devices.
Managed by the Center for Devices and Radiological Health (CDRH), the FDA’s Regulatory Accelerator initiative offers developers of digital health and software-based medical devices access to several new online resources. These resources include:
- A “Resource Index” that features a visual guide to currently available tools, guidances, and engagement opportunities (e.g., webinars) designed to support innovators through every stage of device development, including the regulatory review and approval process;
- “Orientation Meetings” that provide developers with an overview and additional information on the submission process for FDA market approval; and
- A “Medical Device Software Guidance Navigator” that identifies specific FDA guidances applicable to particular digital health device and their alignment with the agency’s electronic Submission Template and Resource (eSTAR).
The FDA says that the intention behind its Regulatory Accelerator initiative is to help new developers of innovative digital health devices learn more about FDA requirements and the FDA review process. The goal is to help foster a more efficient review of FDA submissions, allowing developers to bring innovative digital devices to market more quickly.
For more information about the FDA Regulatory Accelerator initiative, go to https://www.fda.gov/medical-devices/digital-health-center-excellence/regulatory-accelerator?utm_medium=email&utm_source=govdelivery.
