The U.S. Food and Drug Administration (FDA) has released the Regulatory Accelerator, an initiative that supports the FDA’s priority to accelerate cures and treatments by helping digital health innovators bring safe and effective medical devices to market.   

The Regulatory Accelerator features specific FDA resources that have been curated and presented in a user-friendly way to meet the information needs of innovators, including:   

• Resource Index for Digital Health Device Innovators, a visual guide to a selection of FDA tools, engagement opportunities, and guidances available throughout the process of bringing medical device software to market

• Early Orientation Meetings, best practices for sponsors interested in engaging early with the FDA on marketing submissions that include medical device software

• Medical Device Software Guidance Navigator, a resource that largely aligns to relevant sections of the electronic Submission Template And Resource (eSTAR) and provides a streamlined approach for innovators to identify guidances that may be applicable to their device across the development life cycle

New innovators may find these resources especially helpful as they learn about the FDA’s processes for regulatory review and oversight of their medical device software. By using these resources, innovators may accelerate cures and treatments by creating higher quality and complete submissions, facilitate review, help speed time to market, and ultimately increase patients’ access to safe and effective devices.    

The Regulatory Accelerator initiative helps to advance safe and effective medical device software by enhancing collaboration and understanding between innovators and the FDA and supports efficiency and transparency on the journey of bringing a device to market. 

Questions? 

If you have questions about this communication, contact DigitalHealth@fda.hhs.gov.