The Food and Drug Administration (FDA) regularly calls on panels of experts to provide insight on a variety of scientific matters related to drugs, medical devices, and now, digital components increasingly included in regulatory submissions. The agency currently operates 49 committees, each focusing on different therapeutic areas and modalities.
To keep pace with technological advancement, the FDA is forming a digital health advisory committee, tasked with providing the essential perspective on this rapidly evolving sector.
The FDA anticipates this new committee to be fully operational by 2024, with a scope that will include technologies such as artificial intelligence, machine learning, digital therapeutics, wearables, remote patient monitoring, and software. Furthermore, the committee will also explore topics like decentralized clinical trials, patient-generated health data, and cybersecurity.
The digital health advisory committee will consist of nine core members, including the chair, serving terms of up to four years. The FDA plans to enlist additional temporary members for meetings based on the specific topic of discussion. Committee members are expected to bring technical and scientific expertise from various disciplines to ensure that digital health medical devices meet the needs of diverse populations.
As part of the FDA’s commitment to health equity across diverse locations – from homes and workplaces to urban and rural communities – the agency considers digital health technologies pivotal in bringing about transformative changes in care delivery.
In his announcement, Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, emphasized the need to leverage the knowledge of insiders and outsiders alike. Such extensive collaboration will enable the FDA to apply its regulatory authority effectively, reinforcing patient safety while continuing to support innovation.
According to FDA guidelines, all scientific members of committees must be well-qualified experts, capable of analyzing detailed scientific data and grasping its broader public health implications. In addition to these scientific skillsets, consumer representatives are expected to examine the safety and efficacy of products under review from a consumer perspective.
Despite serving as ‘special government employees,’ most committee members still receive a salary for each day of the meeting, along with per diem for travel. However, travel payments may soon be unnecessary due to the virtual format adopted for advisory committee meetings during the pandemic – a practice the FDA seems set to continue. Committee members should anticipate up to four meetings annually.
Those interested in serving on the new digital health advisory committee or wishing to nominate either voting or non-voting members may submit nominations electronically or by mail. The FDA has set a deadline for nominations on December 11.
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