FDA Launches Digital Health Center of Excellence
The U.S. Food and Drug Administration has launched a Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to advance mobile health devices, software as a medical device (SaMD), wearables when used as a medical device, and technologies used to study medical products.
The FDA said it would continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology. The agency is appointing Bakul Patel as the first director. He has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
“The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” said Jeff Shuren, M.D., J.D., director of CDRH, in a statement. “In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”
The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high-quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. The Center is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.
The Digital Health Center of Excellence also seeks to innovate in terms of regulatory approaches to provide efficient and least burdensome oversight by providing clarity on regulation by developing cross-cutting digital health guidance, and developing novel, efficient medical device regulatory approaches that are least burdensome while meeting FDA standards.
An example the FDA cites is the Software Precertification (Pre-Cert) Pilot Program, which will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market.
The goal of the program is to have tailored, pragmatic, and least burdensome regulatory oversight that assesses organizations (large and small) to establish trust that they have a culture of quality and organizational excellence such that they can develop high-quality SaMD products, leverages transparency of organizational excellence and product performance across the entire lifecycle of SaMD, utilizes a tailored streamlined pre-market review, and leverages unique post-market opportunities available in software to verify the continued safety, effectiveness, and performance of SaMD in the real world.
