FDA establishes new Digital Health Advisory Committee to address growing role of technology

From time to time, FDA convenes groups of outside experts to review experimental drugs and medical devices and provide insight on scientific matters that raise questions. The FDA has 49 committees and panels focused on various therapeutic areas and treatments. As regulatory submissions increasingly include digital components, authorities want to ensure they are properly informed about these technologies. It plans to add a digital health advisory board that will be responsible for providing that perspective.

FDA expects the new advisory committee to become fully operational in 2024. The committee will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. Additionally, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, cybersecurity, and more.

The committee consists of nine core voting members, including the chairperson. The maximum term of membership is four years. The committee also includes ad hoc members selected for the meeting, depending on the meeting theme. FDA seeks members who bring technical and scientific expertise from a variety of disciplines and backgrounds to ensure digital health medical devices are designed and targeted to meet the needs of diverse populations. said.

In announcing the new advisory committee, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the FDA aims to improve health equity in a wide range of settings, including homes, workplaces, urban environments, and rural areas. He said that The Agency believes that digital health technology is essential to achieving this transformation in healthcare delivery.

“As digital health technologies advance, the FDA must leverage internal and external knowledge to ensure that regulatory authority is appropriately applied in a way that protects patient health while continuing to support innovation.” said.

FDA requires that for all committees, scientific members must be qualified experts in the field with the ability to analyze detailed scientific data and understand its public health significance. ing. The qualifications of a consumer representative include the ability to analyze scientific data and analyze the safety and effectiveness of the product under review from a consumer perspective.

Most committee members work as “special civil servants” and are paid a salary and a per diem allowance for travel expenses on each meeting day. However, paying for transportation may not be necessary. During the pandemic, advisory committee meetings have been conducted entirely virtually, and the FDA appears to be continuing that practice. Committee members can expect to meet up to four times a year.

Anyone interested in serving on the new Digital Health Advisory Committee or nominating a voting or non-voting member to the organization can submit a nomination electronically or by mail . The FDA has set a December 11 deadline for nominations.

Photo courtesy: FDA