# FDA Launches TEMPO Pilot Program for Digital Health Devices — First Participant Selected July 22

> fda · REPORTED · 2026-07-22

The FDA announced the selection of the first participant in its TEMPO (Transparent Evidence-based Machine learning and Performance Outcomes) pilot program for digital health devices on July 22, 2026, signaling a new regulatory pathway framework designed to streamline evidence generation and authorization for AI and software-based medical devices.

About FDA: The FDA's TEMPO pilot is a new regulatory initiative aimed at establishing transparent, evidence-based performance standards for digital health and AI-enabled devices to modernize the authorization pathway for software as a medical device.

- Company: FDA
- Sector: digital health
- Primary source: https://www.fda.gov/news-events/fda-newsroom/press-announcements

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.