FDA TEMPO Pilot for Digital Health Devices: Enforcement Discretion, CMS ACCESS Model, Real-World Evidence, and the New Regulatory Pathway for Chronic Disease Technology

What Is the TEMPO Pilot?

On December 5, 2025, the FDA's Center for Devices and Radiological Health (CDRH) announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot — a voluntary program that represents a fundamental shift in how the agency approaches digital health device regulation. The formal Federal Register notice was published on December 8, 2025 (90 FR 56768). The FDA began accepting statements of interest on January 2, 2026.

TEMPO is designed to promote access to certain digital health devices while safeguarding patient safety. Under the pilot, manufacturers of eligible digital health devices can request enforcement discretion for certain FDA premarket requirements, including premarket authorization and Investigational Device Exemption (IDE) requirements, while deploying their devices in clinical settings and collecting real-world performance data.

FDA Commissioner Marty Makary framed the initiative as part of the agency's evolving approach: "The TEMPO pilot marks a major step in the agency's plan to support technology-enabled care, strengthen chronic disease management, and expand health care access for patients nationwide."

Key Program Parameters

The Four Clinical Focus Areas

TEMPO targets four high-burden chronic disease categories where digital health devices have the greatest potential to improve patient outcomes. The program expects to select up to approximately ten U.S.-based manufacturers in each area, reflecting a broad spectrum of company sizes and maturities.

1. Early Cardio-Kidney-Metabolic Conditions

Focus on early-stage chronic conditions including:

• Hypertension
• Dyslipidemia
• Obesity
• Prediabetes

Digital health devices in this category might include remote monitoring platforms, AI-driven risk assessment tools, connected blood pressure monitors, and lifestyle management applications that help patients manage early cardiometabolic risk before disease progression.

2. Established Cardio-Kidney-Metabolic Conditions

Focus on diagnosed chronic conditions including:

• Cardiovascular disease
• Diabetes (Type 1 and Type 2)
• Chronic kidney disease
• Heart failure

Devices might include continuous glucose monitors used in new clinical contexts, remote hemodynamic monitoring systems, medication adherence platforms, and AI-powered clinical decision support for chronic disease management.

3. Musculoskeletal Conditions

Focus on chronic musculoskeletal conditions including:

• Chronic back pain
• Osteoarthritis
• Chronic joint pain

Devices in this category could include digital therapeutics for pain management, sensor-based movement analysis platforms, remote physical therapy guidance systems, and activity monitoring devices designed to support musculoskeletal rehabilitation.

4. Behavioral Health Conditions

Focus on behavioral and mental health conditions including:

• Depression
• Anxiety
• Substance use disorders

Eligible devices might include digital cognitive behavioral therapy (CBT) platforms, AI-driven mental health screening tools, remote patient monitoring for behavioral health indicators, and prescription digital therapeutics for substance use disorders.

How TEMPO Works: Enforcement Discretion Framework

The TEMPO pilot introduces a risk-based enforcement approach that is fundamentally different from traditional FDA premarket review. Here is how it works:

Traditional Pathway vs. TEMPO Pathway

What Enforcement Discretion Means

Under TEMPO, FDA exercises enforcement discretion over specific regulatory requirements. This means the agency does not intend to take enforcement action against manufacturers for distributing a device without premarket authorization, provided the manufacturer:

1. Is participating in the TEMPO pilot in good faith
2. Is using the device for an intended use covered by the pilot
3. Is actively collecting, monitoring, and reporting real-world performance data
4. Continues to meet device safety and quality requirements

Importantly, enforcement discretion is not the same as clearance or approval. Devices deployed under TEMPO are not FDA-cleared or FDA-approved. The manufacturer must ultimately pursue traditional marketing authorization based on the real-world evidence generated during the pilot.

What Is NOT Covered

TEMPO enforcement discretion does NOT extend to:

• Quality System Regulation (QSR) / Quality Management System Regulation (QMSR) requirements — manufacturers must still comply with 21 CFR Part 820
• Medical device reporting (MDR) obligations under 21 CFR Part 803
• Registration and listing requirements
• Labeling requirements beyond enforcement discretion scope
• Any device with existing FDA authorization for the proposed intended use (already on the market)

The CMS ACCESS Model Connection

TEMPO is explicitly linked to the Centers for Medicare and Medicaid Services (CMS) Innovation Center's Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Understanding this connection is critical because it creates the commercial and payment infrastructure that makes TEMPO participation viable.

What Is the ACCESS Model?

The ACCESS model is a CMS Innovation Center initiative launching July 5, 2026, designed to expand technology-enabled integrated care for Medicare beneficiaries with chronic conditions. Key features include:

• Outcome-aligned payments: Recurring payments tied to measurable health outcomes rather than service volume
• Technology-supported care: Clinicians can integrate technology-supported care for chronic disease management
• Performance monitoring: CMS monitors clinician performance and publishes risk-adjusted outcomes
• Four clinical tracks: Aligned with the same four clinical areas as TEMPO

How TEMPO and ACCESS Work Together

The integration means that TEMPO participants can deploy their digital health devices in a clinical context where CMS is actively reimbursing technology-enabled care, solving the classic "chicken-and-egg" problem of digital health commercialization: getting both regulatory permission and reimbursement simultaneously.

ACCESS Application Timeline

• January 12, 2026: ACCESS model applications opened
• April 1, 2026: ACCESS application deadline for first performance period
• July 5, 2026: ACCESS model launches (first performance period begins)

How to Apply for TEMPO

Step 1: Submit a Statement of Interest

The FDA is accepting statements of interest by email at FDA-TEMPOPilot@fda.hhs.gov from manufacturers interested in participating. The statement should be titled "Statement of Interest for Participation in the TEMPO Pilot" and include:

1. Proposed indications for use: Identifying the intended use to improve patient outcomes in one of the four ACCESS clinical use areas
2. Manufacturer name and device description: Basic company information and a description of the digital health device
3. Current FDA authorization status: Any current authorizations or prior FDA interactions related to the device
4. Enforcement discretion request: If applicable, a specific request for enforcement discretion, explaining why the device is not currently authorized for the proposed intended use

Step 2: FDA Follow-Up

Upon receipt of the statement of interest, the FDA reviews submissions and follows up with certain potential pilot participants to request additional information. As of May 2026, the FDA:

• Began sending follow-up requests in March 2026
• Continues to consider new statements of interest
• Intends to continue sending follow-up requests to selected applicants

Step 3: Additional Information Submission

If the FDA sends a follow-up request, the types of information that may be requested include:

• Detailed device technical description and software architecture
• Risk analysis and mitigation strategies
• Proposed real-world data collection plan
• Cybersecurity documentation
• Patient safety monitoring plan
• Prior clinical data or evidence supporting the device
• Manufacturing and quality system information

Step 4: Selection and Participation

The FDA plans to select up to approximately 10 manufacturers per clinical area, choosing participants who "reflect a broad spectrum of manufacturers" — meaning companies of various sizes, types, and maturities. Selected manufacturers enter the pilot and begin deploying their devices under enforcement discretion while collecting real-world performance data.

Key Dates and Timeline

Regulatory Strategy Considerations for Digital Health Companies

Who Should Consider TEMPO

TEMPO is most relevant for digital health companies that:

• Have a device targeting one of the four chronic condition areas
• Do not yet have FDA clearance or approval for the proposed intended use
• Can demonstrate a reasonable safety profile based on existing data
• Have the infrastructure to collect, monitor, and report real-world performance data
• Want to generate real-world evidence to support a future marketing submission
• Are targeting the Medicare population (via the ACCESS model alignment)

Who Should NOT Use TEMPO

TEMPO may not be appropriate for companies that:

• Already have FDA authorization for the intended use (not needed)
• Have devices classified as Class III or high-risk (enforcement discretion is for appropriate risk levels)
• Cannot commit to robust real-world data collection and reporting
• Are not ready for commercial deployment (the program assumes actual patient use)
• Target conditions outside the four clinical areas

TEMPO vs. Other FDA Digital Health Programs

TEMPO is distinct from these other programs because it combines regulatory flexibility with a payment model (ACCESS) and requires active real-world evidence generation.

The Bigger Picture: FDA's Evolving Digital Health Strategy

The TEMPO pilot is part of a broader shift in FDA's approach to digital health regulation that accelerated in early 2026:

1. January 6, 2026: FDA updated its General Wellness guidance, expanding the scope of products that qualify as non-devices, particularly for wearables measuring physiologic parameters
2. January 6, 2026: FDA updated its Clinical Decision Support (CDS) guidance, clarifying enforcement discretion for certain CDS functions
3. January 2, 2026: TEMPO pilot launched, creating a new pathway for digital health devices targeting chronic conditions
4. February 2026: QMSR enforcement began, bringing ISO 13485-aligned quality requirements for device manufacturers

Together, these changes signal the FDA's intent to take a more flexible, risk-based approach to digital health regulation — while maintaining robust safety oversight through real-world monitoring and reporting requirements.

Practical Checklist for TEMPO Participation

If your company is considering the TEMPO pilot, here is a practical checklist:

• Identify which of the four clinical areas your device targets
• Determine whether your device currently has FDA authorization for the proposed intended use
• Draft a statement of interest with proposed indications, device description, and authorization status
• Prepare supporting documentation (risk analysis, safety data, data collection plan)
• Submit the statement of interest via email to the FDA contact listed in the Federal Register notice
• Monitor for FDA follow-up requests (the FDA is sending these on a rolling basis)
• If selected, develop a comprehensive real-world data collection and reporting plan
• Ensure QMSR compliance (21 CFR Part 820) — this is NOT covered by enforcement discretion
• Coordinate with CMS ACCESS model application if targeting Medicare population
• Plan for future marketing submission based on real-world evidence generated during the pilot

Key Takeaways

1. First-of-its-kind program: TEMPO is the FDA's first pilot to combine enforcement discretion for digital health devices with a CMS payment model, creating a parallel pathway to market that does not require traditional premarket authorization.

2. Four clinical areas: The program covers early and established cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions — some of the highest-burden chronic disease categories in the U.S.

3. Real-world evidence focus: TEMPO prioritizes real-world data collection over preclinical and clinical trial data, representing a shift toward evidence-based enforcement discretion.

4. CMS integration: The ACCESS model provides the reimbursement infrastructure that makes TEMPO commercially viable for Medicare-focused digital health companies.

5. Not a substitute for clearance: TEMPO is a stepping stone, not a replacement for marketing authorization. Manufacturers must ultimately pursue traditional FDA pathways based on the real-world evidence generated during the pilot.

6. Limited participation: With approximately 10 manufacturers per clinical area, TEMPO is selective. Early application is advantageous.

Last updated: May 29, 2026