Staying on TEMPO: Five Things for Digital Health Companies to Know About the FDA’s New Pilot

Through the Centers for Medicare and Medicaid (CMS) Innovation Center’s new ACCESS model and the US Food and Drug Administration’s (FDA) companion, Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO), CMS and FDA are testing whether limited, supervised real-world use of certain digital health devices in the Medicare program — paired with structured data collection and outcome-based payment — can help close the longstanding gap between innovation, evidence development, regulatory authorization, and insurance coverage.

In this alert, we focus specifically on TEMPO and what digital health companies should understand about the FDA’s new enforcement discretion pilot.

1. What Is TEMPO?

TEMPO is a voluntary FDA program that applies targeted, risk-based enforcement discretion to allow limited, clinician-supervised use of certain digital health devices for chronic disease management, with active performance monitoring. The pilot focuses on outpatient and home-based care in four high-burden areas.

1. Early cardio-kidney-metabolic conditions (e.g., hypertension and prediabetes).
2. Cardio-kidney-metabolic conditions (e.g., cardiovascular disease and diabetes).
3. Musculoskeletal conditions (e.g., chronic back pain).
4. Behavioral health (e.g., depression and anxiety).

The FDA expects to select a small cohort of diverse manufacturer participants (up to roughly 10 per use area) from statements of interest. Participants may deploy software, wearable, sensor-based, or AI-enabled devices in routine care settings, collect and report real-world data, and work toward building an evidence package sufficient to support a future FDA marketing submission. In return, FDA may exercise tailored enforcement discretion from certain requirements (potentially including premarket and investigational provisions), provided participants commit to defined risk mitigations, active monitoring, and a time-bound plan to seek the appropriate marketing authorization.

TEMPO operates alongside the Advancing Chronic Care with Effective, Scalable Solutions Model (ACCESS) under which CMS pays participating providers to deliver integrated, technology-enabled chronic care to Medicare beneficiaries and ties payment to patient outcomes. By running the programs in parallel, the FDA and CMS can observe device performance in real-world clinical settings and use the resulting evidence to inform both regulatory and payment decisions.

Importantly, TEMPO is not a coverage program and not a marketing authorization pathway. TEMPO sits upstream of the three FDA marketing device pathways: 510(k) clearance based on substantial equivalence to a predicate device, De Novo risk-based classification for novel low‑ to moderate‑risk devices, and premarket approval for high‑risk devices. It also differs from Breakthrough and the Safer Technologies Program, which are FDA programs that expedite development and review, and from the Total Product Life Cycle Advisory Program Pilot, an advisory program that accelerates interactions and helps de‑risk submissions. TEMPO instead enables limited, pre‑authorization use in routine care within ACCESS under defined guardrails, with structured data collection and safety monitoring.

2. What Problem Is TEMPO Trying to Solve?

TEMPO is designed to address the familiar “chicken-and-egg” problem in digital health. Companies struggle to obtain FDA authorization and payer uptake without real-world outcomes data, while providers and payers are reluctant to adopt technologies without regulatory clearance and evidence. By aligning FDA enforcement flexibility with ACCESS’s outcome-aligned payment incentives, TEMPO allows limited, supervised use to occur in parallel with evidence generation.

In this setting, developers can generate outcome-focused real-world evidence, move more quickly into meaningful clinical use, and translate performance data into the package needed for FDA authorization and payer acceptance. The FDA has indicated that it may use “sprint”-style engagements with participants to help finalize endpoints, analyses, and timelines.

TEMPO is not a guarantee of clearance, approval, or payment. Enforcement discretion is time-limited and contingent on risk controls, active monitoring, and continued progress toward a marketing submission. The FDA retains the ability to narrow or withdraw discretion if safety concerns arise or milestones are not met.

3. What Is Still Unclear About TEMPO?

Key operational details remain unsettled. The FDA has not pre-defined the precise scope, conditions, baseline evidence thresholds, or duration of enforcement discretion, nor how guardrails may evolve as real-world performance data emerge. The FDA-CMS partnership also raises open questions, including how quickly ACCESS participants will contract for and integrate pilot devices, how ACCESS outcome measures will align with device-level performance goals, and how privacy and data-sharing arrangements will be structured.

Selection criteria introduce additional planning uncertainty. The FDA has stated that it “expects” to admit up to approximately 10 US manufacturers per clinical area and will screen out devices that pose a potential for serious risk, but practical thresholds are not yet defined. While the FDA has identified materials it may request after a statement of interest, the amount and quality of pre-existing evidence needed to earn enforcement discretion has not been specified.

4. What Are the Key TEMPO Dates for Digital Health Companies?

The FDA will begin accepting statements of interest on January 2, 2026, and expects to issue follow-up information requests around March 2, 2026. In parallel, CMS’s ACCESS model is expected to open applications in early 2026, with applications due by April 1, 2026, for the first performance period beginning July 1, 2026.

The FDA has not yet published dates for TEMPO selection decisions, or a formal program start date, but indicates that manufacturers will be notified following review of submitted materials and any follow-up responses.

5. What Should Digital Health Companies Do Now?

TEMPO should not be read as a wholesale rewrite of device regulation or as permission to loosen compliance, stretch indications, or market unsubstantiated claims. Indeed, the FDA’s recent warning letter to Whoop, and the putative class action that has followed (as we discussed in our prior alert), illustrate how quickly regulatory issues can cascade into broader legal exposure.

Instead, TEMPO signals that the FDA and CMS are attempting to build a pragmatic bridge between supervised clinical use and the evidence required for authorization and payment, while recognizing the potential of digital health technologies to improve outcomes and manage chronic disease. Companies that see a potential fit should begin planning now and, given the limited number of available slots and remaining uncertainties, should preserve their options by advancing a traditional marketing pathway in parallel so progress toward market launch continues even if a TEMPO opportunity does not materialize.

ArentFox Schiff regularly advises digital health, device, and life sciences companies on FDA regulatory strategy, CMS innovation models, enforcement risk, and commercialization planning. If you have questions about how TEMPO, ACCESS, or related initiatives may affect your business, please contact one of the authors or your usual ArentFox Schiff attorney.