September 13, 2017

FDA to staff new digital health unit

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports.

The FDA intends to build a group of experts who are experienced with software lifecycle management, mobile medical apps, medical device interoperability, cybersecurity, digital health product development, and machine learning.

Responsibilities of the group will include developing and implementing regulatory policy, identifying modifications to premarket and postmarket reviews of digital health products, and providing training on new regulations and procedures.

The FDA has officially kicked off a hiring process to fill more than a dozen positions within the agency’s new digital health unit. The government’s job board lists two open positions for “interdisciplinary engineer” that will help develop and implement new policies for regulating innovative health devices.

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