FDA Launches TEMPO: What Digital Health Innovators Need to Know Now
On December 5, 2025, the U.S. Food and Drug Administration (“FDA”) announced a ground-breaking new initiative: the Technology-Enabled Meaningful Patient Outcomes (“TEMPO”) pilot developed by the Center for Devices and Radiological Health (“CDRH”). TEMPO was launched with the goal of accelerating responsible access to certain digital health technologies used in chronic disease care.
The TEMPO pilot applies to a broad range of digital health devices, which may include:
Software as a Medical Device (“SaMD”) and Software in a Medical Device (“SiMD”)
Digital Therapeutics (“DTx”)
Certain wearables, connected sensors, and remote monitoring peripherals
Integrated Software + Hardware platforms
Artificial Intelligence or Machine Learning
TEMPO signals FDA’s growing recognition that digital health innovation inevitably moves faster than traditional device approval pathways, and that regulators MUST adapt to modern development cycles in order to get innovations to market faster while still maintaining patient safety.
Importantly, the TEMPO pilot is closely aligned with the CMS Innovation Center’s newly announced value-based care initiative, the ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions). Under ACCESS, participating providers may receive recurring outcomes-aligned payments for technology-enabled management of chronic conditions. TEMPO creates a regulatory companion pathway whereby digital health device companies participating in ACCESS may seek temporary enforcement discretion while collecting real-world data to support future FDA authorization.
How TEMPO Works: The Essentials
TEMPO is voluntary. Device makers can submit a statement of interest beginning January 2, 2026.
The pilot aims to select up to 10 manufacturers per clinical use area, across four broad categories: early cardio-kidney-metabolic; full cardio-kidney-metabolic (e.g., heart failure); musculoskeletal; and behavioral health. That could mean as many as ~40 devices in total.
Under TEMPO, manufacturers may request that FDA exercise enforcement discretion, meaning the agency may temporarily waive requirements such as premarket authorization or investigational device restrictions while the device is used in real-world settings under ACCESS.
In exchange, manufacturers must collect and share real-world performance data (real-world data or “RWD”) to generate real-world evidence (“RWE”) about safety, effectiveness, and patient outcomes. That data will inform later full marketing authorization submissions.
Why is TEMPO a Significant Opportunity for Digital Health Companies?
1. Regulatory pathway that’s more flexible and in-step with digital health’s pace
Traditional device approval pathways often struggle to keep up with the rapid, iterative design cycles typical of digital health technologies (especially software, wearables, remote monitoring, etc.). TEMPO embraces a “risk-based enforcement” approach tailored to digital tools — signaling that FDA is adapting regulatory oversight to the realities of modern digital health development.
This flexibility should lower a major barrier for innovators, especially early-stage companies, allowing them to deploy technologies sooner while collecting real-world evidence.
2. Opportunity for AI-enabled devices
AI-enabled digital health technologies stand to benefit significantly from TEMPO. Many AI/ML tools struggle to generate the prospective, high-quality evidence required for traditional FDA submissions. TEMPO creates a controlled pathway for these companies to deploy their technology under enforcement discretion, gather rigorous real-world data, and convert it into real-world evidence to support future authorization. It also enables validation of novel endpoints, assessment across diverse populations, and collection of the longitudinal performance data that AI models typically need but rarely have early on.
Just as importantly, TEMPO offers a safe environment to observe algorithm performance in clinical workflows, monitor for model drift, refine usability and safety features, and understand real clinician interaction patterns. For adaptive or continuously learning models, TEMPO may be the most practical way to build the evidence base required for Predetermined Change Control Plans and emerging FDA AI frameworks. For many AI innovators, this pilot may represent the clearest, most efficient route to deploy, measure, and validate their technology at scale.
3. Alignment with payment/reimbursement model (CMS ACCESS) improves commercial viability
By tying TEMPO to the CMS ACCESS model, FDA and CMS are aligning regulatory flexibility with payment reform. That means digital health developers may finally be able to deliver devices to patients in a way that is reimbursable — not just as one-off consumer gadgets, but as part of reimbursed chronic care management and outcome-based care.
That could be especially attractive for companies targeting chronic conditions like prediabetes/diabetes, hypertension, heart failure, behavioral health (e.g., depression or anxiety), or musculoskeletal conditions.
4. Potential for real-world data and evidence that meet FDA standards
Because TEMPO requires collection and reporting of real-world data, including outcomes, companies participating will generate high-quality data that could accelerate subsequent clearance or authorization. Over time, this evidence could strengthen the case for broader clinical adoption, payer coverage, and integration into care workflows.
5. Opportunity for devices with limited or narrow clearances
TEMPO also offers a pathway for companies whose technologies already hold FDA clearance, but under indications that do not fully align with the ACCESS Model’s chronic-care focus. Through TEMPO, these devices may be used within ACCESS on an off-label basis under enforcement discretion, allowing companies to evaluate how their technology performs in a new clinical context. This creates an efficient, lower-friction route to generate real-world evidence that can support expanded indications, updated labeling, or subsequent FDA submissions, significantly accelerating label expansion compared to traditional premarket study requirements.
6. Broad applicability, from low-acuity to complex chronic disease
TEMPO’s scope is broad: from early-stage cardiometabolic conditions (like prediabetes) to more complex conditions (heart failure), behavioral health, musculoskeletal — meaning a wide range of digital health solutions may qualify. This is not limited to narrow, high-risk devices; instead, tools for everyday chronic disease management, remote monitoring, patient engagement, behavior change, and more may all be in scope.
Important Considerations and Risks
Participation is limited: FDA expects to select only a modest number (≈ 10 per use area). That means competition will be keen; not everyone who applies may be accepted.
Real-world data requirements are nontrivial: Devices must collect, monitor, and report performance and outcomes. That means companies must have robust data-collection, analytics, privacy, and compliance infrastructure — and be ready to commit resources to build that.
No guarantee of reimbursement or uptake: While TEMPO is linked to the CMS ACCESS model, inclusion in the pilot does not automatically guarantee long-term reimbursement, clinician adoption, or commercial success. Regulators and payers may still require strong evidence, and providers may be slow to integrate new digital tools.
Risk still matters: The “enforcement discretion” is not a full waiver. FDA will still expect proper labeling, safety oversight, adverse event reporting, and risk-mitigation. Companies must maintain high standards to safeguard patients and avoid regulatory backlash.
A Watershed Moment for Digital Health Innovators
For digital health companies (especially those targeting chronic disease management, remote monitoring, behavioral health, and integrated care), TEMPO represents one of the clearest signals yet that regulatory and reimbursement policy is shifting in their favor.
Smaller innovators and startups may finally have a realistic, lower-cost path to deploy products to real patients without waiting years for formal clearance, enabling iterative, real-world development and faster learning cycles.
Companies with existing products lacking FDA clearance may consider applying to TEMPO to bridge the gap: deploy now, gather data, and build a path toward full authorization based on real-world evidence.
For investors and founders, TEMPO could de-risk some of the regulatory uncertainty that has previously hampered digital health, making chronic-care digital health companies more investable.
For health systems and provider organizations, the TEMPO + ACCESS combo may enable a new wave of technology-enabled, outcome-oriented chronic care models.
In short, TEMPO may mark the beginning of a new paradigm: digital health tools not as sidelined add-ons, but as first-class components of chronic disease care, supported by both regulators and payers.
Nixon Law Group can Help: Next Steps for Digital Health Companies
Evaluate whether your software or hardware device could map to one of TEMPO’s four clinical use areas.
Begin preparing a “statement of interest” for submission starting January 2, 2026.
Ensure you have the infrastructure to collect, secure, and analyze real-world data — including privacy compliance, data interoperability, adverse-event monitoring, and outcome measurement.
Engage with clinical partners and payers early, especially those aligned with chronic disease care, to position your tool as part of a broader care delivery model (e.g., under ACCESS or similar value-based frameworks).
Use TEMPO participation to generate evidence and build a compelling case for FDA clearance — potentially giving you a head start over competitors once the pilot ends.
Key Takeaway
TEMPO represents a major policy shift: FDA and CMS are jointly supporting the development, evaluation, and reimbursement of digital health technologies as core components of chronic disease care. For companies building SaMD, DTx, remote monitoring tools, wearables, or connected hardware, the door is now open to a more modern, evidence-driven path to market—one that aligns regulatory rigor with real-world deployment and reimbursement.