FDA closed out 2025 – and opened the door to 2026 – with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s a regulatory expectation.

In December, the U.S. Food and Drug Administration announced the launch of a new Digital Health Devices pilot program known as TEMPO (Technology, Evidence, Monitoring, and Performance Outcomes). The pilot is designed to advance patient access to digital health technologies while maintaining FDA’s core mandate: ensuring safety and effectiveness.

FDA plans to begin collecting statements of interest in early 2026, making now the right time for sponsors to understand what TEMPO represents, and how it may influence regulatory strategy well beyond the pilot itself.

What is TEMPO?

While FDA has long supported innovation in digital health (including SaMD, AI/ML-enabled devices, and connected technologies), TEMPO reflects a shift from pre-deployment validation alone toward continuous, real-world performance oversight.

At a high level, TEMPO is intended to explore:

• How digital health devices perform after deployment in real-world settings
• How sponsors can generate, monitor, and use real-world data (RWD) to support regulatory confidence
• How FDA and sponsors can work together to reduce friction without compromising patient safety

In other words, TEMPO is less about “Can this technology work?” and more about “How does it actually work once it’s in use?”

The Bigger Regulatory Signal: Outcomes, Not Promises

TEMPO aligns with several broader regulatory trends we’re seeing converge:

• Increased reliance on real-world evidence (RWE): FDA’s recent updates across devices and digital health emphasize relevance, reliability, and auditability of real-world data.
• AI/ML lifecycle oversight: For adaptive algorithms, performance does not stop at clearance. It evolves, requiring monitoring, controls, and change management.
• Patient-centric performance measures: Digital endpoints, usability, and sustained clinical benefit are increcasingly part of the regulatory conversation.

TEMPO suggests FDA is testing new regulatory muscle memory: moving from static reviews to dynamic oversight models that better match how digital technologies behave in the field.

What This Means For Digital Health Sponsors

Even if you don’t plan to participate in TEMPO, the pilot offers a preview of where FDA expectations are headed. Sponsors should assume that future regulatory discussions will increasingly focus on:

1. Real-world performance plans

How will you monitor device behavior post-deployment?
What metrics matter, and how are they captured, analyzed, and trended?

2. Data governance and quality systems

Digital health data pipelines will be scrutinized much like manufacturing processes:

• Defined data sources and controls
• Validation and versioning
• Change management and auditability

3. Regulatory strategy beyond clearance

Clearance or approval is no longer the finish line. Sponsors should expect questions about:

• Ongoing safety and effectiveness assurance
• Algorithm updates and drift
• Feedback loops between performance data and risk management

Why TEMPO Matters Now

FDA’s early call for statements of interest is an invitation, but also a warning: digital health sponsors who wait to think about real-world performance may find themselves behind the curve.

Organizations that already treat postmarket data, analytics, and performance monitoring as part of their regulatory strategy, and not an afterthought, will be better positioned to engage with pilots like TEMPO and future FDA programs.

The QSN perspective

From our vantage point at QSN, we see TEMPO as another step toward a more integrated regulatory model, one where quality systems, data governance, clinical strategy, and regulatory planning intersect earlier and more often.

Ultimately, for digital health sponsors, the question isn’t whether FDA will expect real-world performance evidence – it’s how prepared you’ll be to generate and defend it.

If you’re evaluating digital health regulatory strategy, AI/ML oversight, or real-world performance planning heading into 2026, this is the moment to start building those foundations.