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Medical Devices / Regulatory Affairs

Digital Health Takes the Stage in FDA’s 2018 Policy Roadmap

Jan. 17, 2018

Advancing digital health technologies will take precedence over other FDA efforts in the medical device space this year, the agency’s new 2018 strategic policy roadmap suggests.

Digital health technologies provide a significant opportunity for regulatory modernization as they are “characterized by highly iterative cycles of innovation” and “new software advances are introduced into products sometimes on a near-constant basis,” the 18-page policy roadmap states. 

As part of the FDA’s Digital Health Innovation Plan, there are two main goals identified in the roadmap as a focus this year — finalizing guidance on which digital health products fall outside the scope of FDA authority to take enforcement actions; and developing a tailored regulatory approach that can adapt to rapid innovation through the Pre-Certification Program.

Technology innovation will require the agency to modernize its approach to ensure its policies can address the challenges, such as the increasing time and costs of medical product development.

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