Weekly Policy Update: Advancing Innovation in Digital Health

Over the last year, in fact, FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting technology and medications out to the public. This is evidenced by the new Pre- Certification program which would uproot the way software as a medical device is regulated, with the possibility of deeming a company safe instead of focusing on each individual product.

The FDA first introduced the Pre-Certification program in August of 2017, which would change the way software as a medical device is regulated. The proposes of this is to allow certain companies that the FDA has considered responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway. Some of those companies included Apple, Fitbit and Johnson and Johnson.

The promise of these technologies, and the rapid pace of change in this area, has prompted the FDA to modernize their regulatory approach to better advance safe, effective innovation in this novel area.

The FDA through this is taking a more modern, flexible, risk-based approached to regulation. FDA Commissioner Scott Gottlieb says, that (their) “goal is to responsibly reduce the time and cost of market entry, to make these opportunities accessible to entrepreneurs who haven’t traditionally entered the highly regulated market for medical products, all while assuring that appropriate patient safeguards are in place. We want to help encourage more developers to translate digital advances into clinically actionable tools to benefit patients.”

For these reasons the FDA for their FY 2019 Budget, they proposed to create a Center of Excellence for Digital Health that would advance modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients.

This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. The FDA believes that with the creation of a Center of Excellence, the FDA could commit additional resources to helping developers create innovative products that can benefit patients.

For more information on the recent statement from FDA Commissioner Scott Gottlieb and on the CoE click here.


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