Today we’re announcing three new, significant policy documents to advance the FDA’s approach to the development and proper oversight of innovative digital health tools. We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information. Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.

Given these meaningful benefits from empowering consumers, we believe the FDA must, whenever possible, encourage the development of tools that can help people be more informed about their health. And we recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation. Moreover, we must always lean in the direction of enhancing access to more information – not restricting information flow – given the ability of reliable information to positively impact daily life.

Over the last five years, the FDA has made great strides in adapting our policies to better align our regulatory approach to the iterative nature of digital health products. We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed. In these cases, we must adapt and evolve our policies to make sure we continue to provide a gold standard for oversight, while enabling advancement of beneficial innovations and greater consumer access to technologies that can improve their health.
To this aim, this past summer, we issued the Digital Health Innovation Action Plan, which outlines our efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.

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