• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

FDA Gets Closer to Creating Digital Health Unit


There will be 13 full-time positions dedicated to creating and providing guidance in the emerging subject area.

The FDA is inching closer to the creation of a digital health unit within its Center of Devices and Radiological Health (CDRH).

Established as part of the next steps of the Medical Device User Fee Amendments, the center will be creating 13 new full-time positions focused on digital health. According to Bakul Patel, associate director of digital health in the FDA’s CDRH, these will be expert new hires.

Although not a completely new concept, interest in the topic resurfaced after Patel spoke earlier this month at MedCon, a medical conference in Ohio.

According to published reports, the funding for the digital health unit should be available in the fall when the new fiscal year begins.

This news could not come at a more perfect time. No, not just because I am working on an article about digital health for an upcoming issue, but because the industry desperately needs guidance in this area.

No matter what conference I attend, or who I speak with, regulations, the FDA, and the fear of not being compliant are popular themes. So is the lack of FDA guidance when it comes to digital health.

According to the FDA document, the digital health unit-among other things-will develop software and digital health technical expertise to provide assistance for premarket submissions that include SaMD, SiMD, interoperable devices, or otherwise incorporate digital health technologies; utilize technical experts as appropriate, or when requested by the manufacturer for submissions that include SaMD, SiMD, interoperable devices, or otherwise incorporate novel digital health technologies; and incorporate appropriate metrics for digital health improvements to monitor, track, analyze, and report the results of digital health premarket review timelines.

The unit will also participate in international harmonization efforts related to digital health, including work on developing SaMD and other digital health convergence efforts through the International Medical Device Regulators Forum

While the unit’s task seems very broad, it is a start-a much-needed start that can help launch more tools to guide developers and innovators when incorporating digital into their portfolios.

As you will read in our upcoming feature article, a common theme I’ve heard when talking with experts about digital health is the time it takes to bring a product to market. The tech world moves fast. The FDA and healthcare industry does not.

But, maybe one of the first steps toward true innovation in digital health will be this unit. 

Related Videos
Ashley Gaines
Related Content