FDA Names First Participants in the TEMPO Digital Health Device Pilot (July 22, 2026)

Key takeaways

The U.S. FDA announced on July 22, 2026 the first participants selected for the TEMPO digital health device pilot: SonderMind, Limbic, Cadence and Dexcom. The pilot is intended to expand access to certain digital health devices while safeguarding patient safety. For the participating manufacturers, the FDA intends to exercise enforcement discretion with respect to certain requirements, covering products in behavioral health and early cardiometabolic areas. Medical device companies should evaluate the implications for premarket authorization, real-world data and product labeling.

Source and applicability

• Source organization: FDA CDRH News & Updates
• Original publication date: August 21, 2026
• Source link: https://www.fda.gov/medical-devices/digital-health-center-excellence/participants-selected-tempo-digital-health-devices-pilot

This article is compiled and translated from public information published by FDA CDRH News & Updates. Specific requirements are subject to the regulator's latest official release. The Chinese-language summary of this update, published on this site on August 25, 2026, covered the same participant list, the scope of enforcement discretion and the implications for premarket review, real-world data and labeling.

Full English translation of the source content

On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced the first participants selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) digital health device pilot. The list of TEMPO pilot participants selected by the FDA is set out in the table below.

Each participating manufacturer selected for TEMPO plans to provide devices used to deliver care that is expected to be covered under the "Advancing Chronic Care with Effective, Scalable Solutions" (ACCESS) model of the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare & Medicaid Services (CMS), and aims to improve health outcomes for U.S. patients managing certain chronic conditions. For these manufacturers, when a manufacturer's device is provided to, or by, a CMMI ACCESS participant for its intended use of improving patient outcomes, and is used to deliver care expected to be covered under the ACCESS model, the FDA intends to exercise enforcement discretion with respect to certain requirements, such as premarket approval and investigational device requirements.

The TEMPO pilot is intended to expand access to certain digital health devices while safeguarding patient safety. The effectiveness of the selected devices for the intended uses covered by their participation in the pilot has not been evaluated by the FDA. Manufacturers participating in the TEMPO pilot will collect, monitor and report real-world data related to their devices' intended uses in order to improve patient outcomes, whether the device is used by the manufacturer itself as an ACCESS participant or by another participating ACCESS organization.

TEMPO pilot participants

The FDA has selected the following participants for the TEMPO pilot, with the expectation that each manufacturer's device will be provided to, or by, CMMI ACCESS participants for the intended uses listed below. The FDA plans to update this table as additional TEMPO pilot participants are selected.

SonderMind, Inc.

Device name: SonderMind Assistive Care Application (SACA)

Clinical use area: Behavioral health (BH)

Intended use evaluated in the TEMPO pilot: Intended to improve (reduce) depression and anxiety levels in adults aged 22 years and older who are receiving treatment for moderate depression and/or anxiety, as an adjunct to psychotherapy and/or pharmacotherapy interventions, delivered through a smartphone application. Contraindications include current suicidality, current manic episode, current comorbid psychosis, and current comorbid post-traumatic stress disorder (PTSD).

Limbic Inc.

Device name: Unpacked

Clinical use area: Behavioral health (BH)

Intended use evaluated in the TEMPO pilot: Intended to deliver evidence-based psychotherapy protocols to adults receiving talking-therapy sessions through an AI voice agent within a structured outpatient behavioral health service model. Unpacked is indicated to treat Medicare beneficiaries with clinically significant depression and/or anxiety through structured cognitive behavioral therapy-based treatment. It is intended to improve patient outcomes by increasing access to structured psychotherapy, enabling measurement-based care (MBC), and supporting clinical oversight through real-time safety flagging and outcome monitoring. Contraindications for Unpacked include: suicidal or homicidal ideation; moderate to severe dementia or severe cognitive impairment; any psychiatric disorder with prominent psychotic features (such as schizophrenia, major depressive disorder with psychotic features, or bipolar I disorder); active severe self-harm without suicidal intent; complex disorders without psychotic features (such as bipolar II disorder and personality disorders); substance use disorder as the primary condition or with a risk of dangerous intoxication or withdrawal; eating disorders of any severity (including untreated anorexia nervosa, bulimia nervosa and binge eating disorder); acute unstable physical health conditions; pregnancy; frailty and advanced illness (patients aged 81 years and older with indicators of frailty, patients receiving hospice or palliative care, or patients aged 66 years and older entering long-term nursing home care within the intervention window); and individuals who do not speak or read English or cannot use a telephone.

Cadence Solutions, Inc.

Device name: HypertensionOS

Clinical use area: Early cardiometabolic (eCKM)

Intended use evaluated in the TEMPO pilot: Supports clinician-supervised, protocol-constrained initiation and dose titration of antihypertensive medication when predefined eligibility criteria and deterministic safety checks are met. HypertensionOS is intended for use by licensed healthcare professionals with prescribing authority, such as physicians or advanced practice registered nurses, to assist in the outpatient management of adult patients diagnosed with stage 2 hypertension at the time HypertensionOS is initiated. Patients who progress from stage 2 hypertension to stage 1 hypertension while being managed with HypertensionOS may continue management with HypertensionOS. Contraindications: none.

Dexcom, Inc.

Device name: Dexcom Glucose Health Program

Clinical use area: Early cardiometabolic (eCKM), cardiometabolic (CKM)

Intended use evaluated in the TEMPO pilot: Intended to enable patients eligible for the ACCESS model, together with their healthcare professionals or caregivers, to monitor metabolic and nutritional status, receive personalized guidance, and access real-time data and AI insights to make informed decisions and behavioral adjustments. The program is intended to assist in screening for prediabetes and type 2 diabetes by integrating digital health metrics. It may also help improve glycemic control and reduce HbA1c in people with prediabetes. Contraindications: none.

Selection

For information on the selection of TEMPO pilot participants, please visit the TEMPO digital health device pilot webpage.

What does this information mean for medical device companies?

Information of this kind, published by FDA CDRH News & Updates, should first be brought into a company's regulatory intelligence and post-market surveillance processes rather than treated as ordinary news. Companies need to determine whether the update is a guidance document, a recall or safety communication, a product authorization, digital health information, quality system information or post-market regulatory information, and to confirm whether it affects an existing registration project or a product under development.

Where the content concerns specific products, testing performance, risk warnings or regulatory action, companies should further assess whether it affects product classification, the 510(k), De Novo or PMA pathway, technical documentation, labeling and instructions for use, quality system records or post-market reporting obligations. Companies pursuing U.S. market registration should record the source link, publication date, scope of applicability and internal conclusions in their project files.

Which materials should companies review?

• The basis for product classification
• Applicable regulatory provisions
• Predicate device or substantial equivalence determinations
• Performance testing
• Software and cybersecurity documentation
• Risk management
• Clinical evidence
• Labeling and instructions for use
• Quality system readiness

Common risks

• Misjudging the applicable FDA pathway
• Overlooking changes in guidance documents
• Insufficient performance test design
• Overly broad labeling claims
• Unclear post-market reporting obligations
• Applying documentation prepared for other markets directly to U.S. registration

Aimeili regulatory interpretation

On July 22, 2026, the U.S. FDA published the first participants selected for the TEMPO pilot and made clear that, in conjunction with the CMMI ACCESS model, it intends to exercise enforcement discretion for participating manufacturers' specified digital health devices with respect to requirements such as premarket approval and investigational device requirements. From the perspective of international medical device registration, this arrangement is not a conventional FDA marketing authorization channel; it is a limited-access pathway operating under a special payment and care model of the CMS Innovation Center. For Chinese companies seeking to enter the U.S. market with digital therapeutics, behavioral health applications or chronic disease management software, this signals that the FDA is exploring flexible regulation in the digital health field, while also indicating that bringing a product to large-scale market access may still require completing a conventional 510(k) or De Novo submission. Companies should therefore first distinguish the legal boundary between "use within the pilot" and "routine commercial marketing," and avoid misreading enforcement discretion as a blanket clearance.

The direct impact on registration strategy is that, if a Chinese company plans to enter the ACCESS/TEMPO ecosystem as a participant or a partner, it needs to assess whether its product's clinical indications match the behavioral health and early cardiometabolic directions on the participant list, and to prepare to collaborate with U.S. medical institutions or manufacturers that hold CMS ACCESS participant status. The FDA exercises enforcement discretion only for devices that are "used to deliver care expected to be covered under the ACCESS model" and for the "intended use of improving patient outcomes." This means that the intended use stated in product labeling and promotional materials cannot exceed that limited scope. At the same time, the pilot requires manufacturers to collect, monitor and report real-world data; if a transition from the pilot to conventional registration is needed in the future, such data can serve as supporting material for clinical evaluation or post-market studies. Chinese companies should incorporate a real-world data system into their long-term planning when developing U.S. registration strategies.

The impact on technical documentation and clinical evaluation should not be overlooked either. Each product on the pilot list is described with detailed intended use and contraindications. SonderMind, for example, is indicated only as an adjunct treatment for adults aged 22 years and older with moderate depression and/or anxiety, and excludes suicidality, mania and other conditions; Limbic's Unpacked excludes a range of psychiatric disorders, cognitive impairment and specific populations. Requirements of this granularity mean that a company's technical documentation, instructions for use, contraindications and user instructions must remain strictly consistent with the intended use evaluated by the FDA. Chinese companies benchmarking against these products need a sufficiently robust documentation system in design verification, usability and clinical evidence in order to meet FDA and CMS safety expectations within a limited timeframe. Because the FDA may still focus on safety and patient protection when exercising enforcement discretion, performance verification and clinical evidence cannot be relaxed merely because premarket review has been waived.

For quality systems and post-market maintenance, manufacturers must be able to continuously collect, monitor and report real-world data. This involves both data management and clinical-trial-grade data integrity issues, and the interfaces with complaint handling, adverse event reporting and FDA inspections. Chinese companies entering this model as remote manufacturers or OEM suppliers need to appoint a local agent with FDA regulatory capability and establish compliance processes aligned with CMMI ACCESS participating organizations and CMS requirements. Given that the FDA has indicated it will update the list as more participants are selected, companies should continue to track this policy window, assess whether future expanded indications or additional products could be brought into the pilot, and at the same time retain a clear route toward eventual conventional marketing authorization.

Business impact

The TEMPO pilot creates a limited commercial window linked to the CMS ACCESS payment model rather than an independent route to the U.S. market. Companies whose digital health products address behavioral health or early cardiometabolic care should evaluate partnership options with ACCESS participants, prepare real-world data collection capabilities that satisfy pilot reporting expectations, and keep labeling and promotional claims strictly within the intended use evaluated by the FDA. Because participation does not replace conventional premarket authorization, dual-track planning — pilot participation plus a 510(k) or De Novo strategy — is the prudent approach for long-term U.S. market access.

FAQ

Does an update to an FDA public webpage necessarily represent a regulatory change?

No. It is necessary to distinguish between news items, guidance documents, database pages, recall information and formal regulatory documents. Material of significance should be verified against the original FDA source and the applicable regulations before any conclusion is drawn.

What should a company do when it sees an FDA update?

First determine whether it affects product classification, the registration pathway, technical documentation or post-market obligations, and then decide whether the project plan needs to be updated.

Review and scope of application

• Content author: Aimeili Regulatory Editorial Team
• Professional review: Aimeili International Medical Device Registration Project Team
• Sourcing principle: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.
• Scope of application: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, test conclusions or legal advice.

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