FDA begins filling positions for its new digital health unit

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Several weeks after the FDA Reauthorization Act officially funded a digital health unit, the FDA is filling 13 new positions.

The Food and Drug Administration has officially kicked off a hiring process to fill more than a dozen positions within the agency’s new digital health unit.

Bakul Patel, the associate director for digital health at the FDA’s Center for Devices and Radiological Health, posted a “digital health advisor” position on LinkedIn Monday morning. The U.S. government’s job board lists two open positions for an “interdisciplinary engineer,” one of which is open to current and former federal employees.

An FDA spokesperson confirmed the agency plans to fill 13 positions in the new digital health unit created under the FDA Reauthorization Act of 2017 signed by President Donald Trump last month.

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According to the job descriptions, the FDA is seeking “talented, innovative, out-of-the-box thinkers with industrial experience” with technical expertise in a broad range of areas including software lifecycle management, mobile medical apps, medical device interoperability, cybersecurity, digital health product development and machine learning.

Major duties include developing and implementing regulatory policy, identifying modifications to premarket and postmarket reviews of innovative digital health products, and providing training on new regulations and procedures.

"Our plan is to build a cadre of experts with a deep understanding and experience with software development and its application to medical devices," Patel said in a statement emailed to FierceHealthcare. "This new staff will work with reviewers, compliance officers, and others within the FDA to improve the quality, predictability, consistency, timeliness, and efficiency of decision making on individual products and firms."

The new positions are the most recent step in the FDA’s broad overhaul to the way it regulates the digital health industry. Last week, Patel announced the agency was recruiting six private-sector experts through an Entrepreneur-in-Residence program to support a new Software Precertification Program that kicked off earlier this month. That pilot program aims to test a new framework on nine digital health companies.