A New Role for the FDA in Medical Device Regulation

Photo: Al Drago/CQ Roll Call via AP Images

June 17, 2019

Project Summary

Advances in artificial intelligence and big data are now allowing individualized nutrition information and advice to be provided by emerging health technologies. These technologies have the potential to provide consumers with more information than ever before about their individual health and could be used to help address nutrition-related health issues like obesity, diabetes, heart disease, and others.

This policy paper examines the role of the U.S. Food and Drug Administration in regulating emerging nutrition technologies. The authors find that emerging nutrition technologies have the potential to help improve consumers’ health outcomes if key conditions are met:

  • Changes must be market-driven, not government-driven.
  • The government must allow disruption in the healthcare industry.
  • Policies should not favor one industry or firm over another.
  • Governance must focus on actual harm as opposed to possible harm.

The authors begin by examining the government’s current approach to nutrition-based health. They then discuss the importance of individualized health recommendations that emerging nutrition technology can offer. Finally, they review the current regulatory framework applied to nutrition devices and provide recommendations for how to encourage innovation in this space that will benefit consumers into the future.

Project Authors
Richard A. Williams
Kathryn Ghani
Download