Monday, February 16, 2026

STAT+: FDA will convene Digital Health Advisory Committee in November

The Food and Drug Administration (FDA) has announced that it will be holding a meeting of external digital health advisors on November 6th. This news, revealed in an email reviewed by STAT, is a promising step towards the advancement of digital health technology.

The FDA, a federal agency of the United States Department of Health and Human Services, is responsible for regulating and supervising the safety and effectiveness of medical products, including digital health devices. With the rapid growth of digital health technology, it is crucial for the FDA to stay up-to-date and informed on the latest advancements in this field.

The meeting, which will be held virtually, will bring together a panel of external advisors who are experts in the field of digital health. These advisors will provide valuable insights and recommendations to the FDA on various digital health topics, including mobile medical applications, software as a medical device, and other emerging technologies.

This meeting is a significant step towards the FDA’s goal of promoting and protecting public health through the regulation of digital health technology. By convening a panel of external advisors, the FDA is demonstrating its commitment to staying at the forefront of this rapidly evolving industry.

The email reviewed by STAT also mentioned that the meeting will include discussions on the FDA’s Digital Health Center of Excellence, which was established in September 2020. This center serves as a resource for both the FDA and the digital health community, providing expertise, support, and guidance on digital health technology.

The FDA’s Digital Health Center of Excellence is a testament to the agency’s dedication to fostering innovation in the digital health space while ensuring the safety and effectiveness of these technologies. By bringing together external advisors, the FDA is seeking to collaborate with industry experts and stakeholders to further advance this mission.

The meeting on November 6th will also provide an opportunity for the FDA to receive feedback on its Digital Health Precertification Program. This program, which was launched in 2019, aims to streamline the regulatory process for digital health products by focusing on the developer’s organizational excellence rather than individual products.

The FDA’s efforts to modernize its regulatory approach to digital health products are commendable. By engaging with external advisors and seeking feedback on its initiatives, the FDA is taking a proactive approach to ensure that digital health technology continues to advance while maintaining the highest standards of safety and effectiveness.

The meeting of external digital health advisors on November 6th is a significant event for the digital health community. It is an opportunity for the FDA to showcase its commitment to promoting innovation and protecting public health in the digital health space.

In conclusion, the FDA’s decision to convene a meeting of external digital health advisors is a positive step towards the advancement of digital health technology. By collaborating with industry experts and seeking feedback on its initiatives, the FDA is demonstrating its dedication to ensuring the safety and effectiveness of these technologies. This meeting is a clear indication that the FDA is committed to staying at the forefront of the digital health industry and promoting the well-being of the public.

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