Accelerating Digital Health Innovation: New FDA Resources for Medical Device Software

The U.S. Food and Drug Administration (FDA) has launched the Regulatory Accelerator initiative, a new set of resources designed to help digital health innovators navigate the process of bringing medical device software to market. The program aims to streamline the regulatory review process, ultimately helping to get safe and effective devices to patients faster.

The Regulatory Accelerator highlights several key tools, including:

• Resource Index for Innovators: A visual guide that maps FDA resources and guidance to each stage of the device regulatory and compliance lifecycle.

  
  

• Early Orientation Meetings: An opportunity for companies to meet with the FDA review team to demonstrate their innovative medical device software and provide an overview before a formal marketing submission.

  
  

• Medical Device Software Guidance Navigator: A tool that helps innovators easily find relevant FDA guidance documents for their device, aligning with the electronic Submission Template And Resource (eSTAR).

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