FDA focuses on digital health and diagnostics in 2018

John Lehmann, Director of Business Development for IMARC Research

US FDA Commissioner Scott Gottlieb provided some key digital health initiatives along with his vision on how he wants the agency to work with the sector in the coming years.

A published list of the commissioner’s priorities titled “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” outlines four priorities:

1. Fighting addiction in the US by focusing on the opioid crisis
2. Increasing innovation and competition
3. Providing consumers with tools to improve their diet and health
4. Boosting FDA’s workforce and ability to more efficiently review products

Gottlieb stressed that the roadmap is not a strategic plan but another way to provide transparency about FDA policies.

The roadmap highlights the potential of digital-health products, including digital-health apps, to provide Americans with better data.  This means empowering consumers to make better health decisions by helping them gain access to effective tools that can provide reliable information on their health.

The roadmap also highlights genomic tests that can give consumers a clear understanding of risks for certain diseases.  The report states “Enabling these opportunities means also seeking better and less burdensome ways to reliably validate the analytical and clinical validity of laboratory-developed tests that consumers and providers increasingly rely on.”

FDA is considering complimentary and voluntary new programs to encourage product developers to seeking the benefits of FDA review through more efficient third-party validation.

FDA has already moved forward with some of these models, including direct-to-consumer genetic-screening services.  The agency plans on taking to Congress regarding additional legislative options to help get products to consumers more efficiently.

What are your thoughts on FDA Commissioner Gottlieb’s roadmap?  Please share your thoughts with us.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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