Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

What is a Center of Excellence?

Formally defined, a “Center of Excellence” is a program within a health care institution that serves as an integrated clearinghouse of specialized know-how across multiple specialties and organizational units.

In this regard, DHCoE would not be alone within the FDA – the Oncology Center of Excellence (OCE) has been in operation since 2017. Authorized by 21st Century Cures Act, OCE exercises oversight of expedited review pathways for oncology therapies.

In keeping with its disease-focused orientation, this oversight extends to small molecule drugs, biologics, and devices, under Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) jurisdiction, respectively. OCE corresponds with each of the operating Centers in providing high-level input and oncology-specific expertise during the review process. However, it remains separate and functionally independent from them; the OCE center director reports directly to the Commissioner.

A Network and a Committee

DHCoE offers a dedicated avenue for coordinating digital health programming within FDA and interfacing with industry, academic, and consumer stakeholders.

It seeks to achieve this through two key structural features: the (1) Network of Digital Health Experts and (2) Digital Health Steering Committee.

The former is a standing body of professional societies who will be consulted periodically. It appears to represent a more robust incarnation of the Collaborative Communities concept of Agency-stakeholder engagement.

The Digital Health Steering Committee is charged with establishing an internal regulatory agenda within CDRH. At present, no formal working group to facilitate cross-cutting FDA response has been announced. For DHCoE to achieve its fullest potential as a center of excellence, a formal committee tasked with coordinating intra-Center dialogue on digital health concerns should be established, akin to OCE’s multidisciplinary Medical Oncology Review and Evaluation (MORE) teams. These bring together medical oncologists, OCE staff, and specialists from the appropriate operating Center to review a given Breakthrough or Fast Track application. A DHCoE analog may mirror a MORE team’s composition and further include personnel from multiple operating Centers, if necessary. This is particularly relevant for combination products leveraging digital health technologies, which face an increasingly uncertain regulatory environment.

Implications

The Division of Digital Health (DDH), within the Office of Strategic Partnerships and Technology Innovation at CDRH currently performs many of the functions DHCoE has been tasked with. The bodies share leadership, both being led by Bakul Patel. It is unclear whether DHCoE supersedes, operates within, or exists alongside the Division of Digital Health. It is clear that unlike OCE, DHCoE will be housed within CDRH and not as a separate, standalone unit parallel to the operating Centers.

Even if DDH’s scope is preserved in DHCoE, the difference in scale may itself be meaningful, drawing additional publicity, importance, and funding to digital health-related activities within FDA.

However, funding sources for DHCoE remain unclear. DHCoE lacks an independent mandate, unlike OCE, which was established under the auspices of the 21st Century Cures Act and received earmarked funding through the national Cancer Moonshot initiative.

The Pre-Cert program, a precertification pilot program for software-based medical devices, may present one vehicle for financial support for DHCoE. The much-hyped program has already been housed within DHCoE. Pre-Cert will likely require statutory approval to advance past the pilot phase, and, if expanded and provided the necessary appropriations, it could drive the growth of DHCoE.

The Digital Health Center of Excellence offers substantial promise as both a digital health nerve center within the FDA and invaluable window between FDA and the public at large. But its establishment comes at a tumultuous juncture in the Agency’s history, amid an ongoing pandemic, political pressure, a consequential election cycle, and staff reorganization.

The Agency acknowledges that DHCoE remains a work in progress, and is actively soliciting public input as it develops the program. Two virtual listening sessions are scheduled for this fall, on October 19 and November 12.

Vrushab Gowda

Vrushab Gowda

Vrushab is a law student at Harvard Law School, as well as an MD candidate at University of North Carolina. He previously served on the masthead of Harvard Journal of Law and Technology and has published in medical literature. His scholarly interests focus on the legal, regulatory, and ethical dimensions of digital health.

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