FDA Announces Pilot to Promote Access to Digital Health Devices

The FDA has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot, meant to promote access to digital health devices while safeguarding patient safety.

The pilot will “evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.” FDA commissioner Marty Makary touts the pilot as a means to “support innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease.”

Under the TEMPO pilot, “participating manufacturers of certain digital health devices will offer devices for an intended use to provide care covered by the CMMI ACCESS model while collecting, monitoring, and reporting real-world performance data. This pilot will help the FDA and CMS better understand how digital health technologies perform in real-life settings and how they may support efforts to improve care for people living with chronic diseases. The pilot supports CMS’s ACCESS Model, which aims to increase beneficiary access to technology-enabled, integrated care.”

Manufacturers can “request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.”