FDA to create centralized digital health unit

From: Health Data Management

By Greg Slabodkin

The Food and Drug Administration is creating a digital health unit within its Center for Devices and Radiological Health in an effort to develop internal technical expertise, and streamline the agency’s software review process and regulation of medical devices.

Among its responsibilities, the digital health unit will work on:

  • Developing software and digital health technical expertise to provide assistance for premarket submissions that include Software as a Medical Device (SaMD), software inside of medical devices (SiMD), interoperable devices or otherwise incorporate novel digital health technologies.

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