FDA Launches Pilot Program to Expand Access to Digital Health Technologies for Chronic Disease Management

SILVER SPRING MD December 6 2025

            The Unites States Food and Drug Administration has announced the launch of a pilot program known as the ‘Technology Enabled Meaningful Patient Outcomes Pilot,’ identified in the agency’s description as the TEMPO pilot. The purpose of the program is to expand access to certain digital health technologies for individuals managing chronic diseases. This Pilot will allow manufacturers of designed digital health devices to request consideration for enforcement discretion under specific conditions set forth by the FDA. Under the pilot, those manufacturers would be able to provide devices in a limited access setting while regulators observe performance and collect real world data. The agency explains that this program is voluntary and that participating manufacturers must share information regarding device safety usability and outcomes.

            The FDA states that the pilot will focus on three categories of chronic disease technologies; these categories include: cardio kidney metabolic health, musculoskeletal health, and behavioral health. The agency also stated that this pilot is intended to support evaluation of how technology may improve the management of these medical conditions and noted that the pilot will be conducted with the involvement of the Centers for Medicare and Medicaid Services, under the authority of existing federal programs. This announcement doesn’t approve or authorize any specific device, and doesn’t relax federal requirements, outside the structure of this pilot; the press release states that enforcement discretion may be considered only within the pilot program, and only under the conditions described by the FDA. The statement further clarifies that the pilot is limited in scope and doesn’t represent a broad or permanent change.

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Sources

The United States Food and Drug Administration official press announcement on the Tempo pilot