FDA Publishes TEMPO Digital Health Device Pilot FAQs (July 9, 2026)

Key Summary

In July 2026, FDA announced the first selected participant in the TEMPO Digital Health Device Pilot and published detailed frequently asked questions clarifying manufacturer eligibility, the application process, and the scope of enforcement discretion. The pilot is linked to the CMS ACCESS Model and covers four clinical use areas: early cardiorenal metabolic, cardiorenal metabolic, musculoskeletal, and behavioral health. It aims to promote innovation through real-world data while safeguarding patient safety. Chinese digital health device companies should assess how their registration strategies align with the FDA marketing pathway.

Source and Applicability

• Source institution: FDA CDRH News and Updates
• Original date: July 20, 2026
• Site publication time: 2026-07-25 00:57
• Source: FDA CDRH News and Updates
• Source URL: https://www.fda.gov/medical-devices/digital-health-center-excellence/tempo-digital-health-devices-pilot
• This article is based on public information from FDA CDRH News and Updates. Specific requirements are subject to the latest official release by the regulatory authority.

Full Translated Core Content

The US Food and Drug Administration launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Digital Health Device Pilot. The pilot is linked to the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model of the Centers for Medicare and Medicaid Services Innovation Center (CMMI). The goals of the TEMPO pilot are to:

• Promote access to certain digital health devices while safeguarding patient safety;
• Evaluate a risk-based enforcement approach to support digital health devices intended to improve patient outcomes for specified conditions;
• Responsibly encourage innovation while collecting real-world evidence to better understand how these devices perform in real-world settings.

Through the TEMPO pilot, manufacturers may request that FDA exercise enforcement discretion for certain requirements when their devices are furnished or used by CMMI ACCESS participants, provided the devices are intended to improve patient outcomes and are used for care expected to be covered by the CMMI ACCESS Model. FDA will work with participants to determine the circumstances in which enforcement discretion applies to the manufacturer's device.

Key dates:

• January 2, 2026: FDA began accepting letters of intent to participate in the TEMPO pilot.
• March 2026: FDA began sending follow-up requests to certain potential pilot participants for additional information to help FDA make participation decisions. FDA continues to consider letters of intent and plans to continue sending follow-up requests to certain potential pilot participants.

For more information on the TEMPO pilot and how to submit a letter of intent, see the Federal Register notice. For more information on the CMMI ACCESS Model, visit the Centers for Medicare and Medicaid Services website.

FDA now offers TEMPO pilot educational modules. Presentations, printable slides, and transcripts are available in CDRH Learn under the Digital Health subsection of Specialty Technical Topics.

Frequently Asked Questions (FAQ)

Clear professional answer: The TEMPO FAQ confirms that the pilot is a limited FDA initiative for US-based manufacturers of finished digital health devices intended to improve outcomes in specified CMMI ACCESS clinical areas. It offers enforcement discretion for certain requirements only when devices are furnished or used by ACCESS participants, and FDA expects participants to pursue marketing authorization using data collected during the pilot.

The following questions and answers are intended to help manufacturers find answers to common questions about the TEMPO pilot. Additional questions may be sent to FDA-TEMPOPilot@fda.hhs.gov.

Eligibility Requirements

Q1: What are the manufacturer eligibility requirements? Manufacturers must be located in the United States. FDA will select digital health device manufacturers that meet the following conditions: the product meets the definition of a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)); the device is intended for use under clinician supervision in combination with outpatient treatment for patients in one of the four CMMI ACCESS clinical use areas; the device does not pose a serious risk to patient health, safety, or welfare; and the device has an intended use to improve patient outcomes consistent with the CMMI ACCESS program.

Q2: How does FDA interpret the located in the United States eligibility requirement for the TEMPO pilot? FDA intends to select manufacturers located in the United States to facilitate FDA oversight of participating manufacturers, such as inspections and access to records. For the TEMPO pilot, FDA intends to consider a manufacturer to be located in the United States if it is a domestic entity formed in a state and has a US federal tax identification number, and if records required by the Quality Management System Regulation, including ISO 13485-related clauses referenced by FDA regulations in Part 820, are stored at a US FDA-registered facility.

Q3: Do devices that have received FDA clearance qualify for the TEMPO pilot? The FAQ addresses certain digital health devices that have not yet received FDA authorization. If such a device is intended to improve patient outcomes in one of the four CMMI ACCESS clinical use areas, namely early cardiorenal metabolic, cardiorenal metabolic, musculoskeletal, and behavioral health, its manufacturer may request participation in the TEMPO pilot.

Q4: Do devices without a functional prototype qualify for TEMPO? No. FDA launched the TEMPO pilot in connection with the CMMI ACCESS Model, a new payment model under which CMS will make periodic payments for managing patients' qualifying conditions. Therefore, the TEMPO pilot applies to finished devices that can be used for care covered by the CMMI ACCESS Model. Through the pilot, manufacturers may request that FDA exercise enforcement discretion and not enforce certain applicable requirements when the device is furnished or used by CMMI ACCESS participants, provided the device is intended to improve patient outcomes and is used for care expected to be covered by the CMMI ACCESS Model. Accordingly, device concepts that are not fully built or deployed may not be suitable for the TEMPO pilot until they are near readiness for use.

Q5: Which ACCESS Model clinical use areas are eligible for TEMPO? The four eligible ACCESS Model clinical use areas are:

• Early cardiorenal metabolic: hypertension, dyslipidemia, obesity or overweight with central obesity markers, or prediabetes;
• Cardiorenal metabolic: diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease;
• Musculoskeletal: chronic musculoskeletal pain;
• Behavioral health: depression or anxiety.

For more information on CMMI ACCESS clinical use areas, see the ACCESS Model application guide on the CMS Innovation Center website or contact CMS at ACCESSModelTeam@cms.hhs.gov.

Q6: Can a device in the TEMPO pilot be used to improve patient outcomes across multiple ACCESS Model clinical use areas? Yes. A device in the TEMPO pilot may have an intended use to improve patient outcomes in more than one of the four CMMI ACCESS clinical use areas, namely early cardiorenal metabolic, cardiorenal metabolic, musculoskeletal, and behavioral health. Manufacturers are not required to designate a single primary track.

Q7: Are the specific conditions identified for each ACCESS Model clinical use area in the TEMPO pilot Federal Register notice the only eligible conditions? Yes. To be eligible for the TEMPO pilot, the manufacturer's device must be intended to improve outcomes for patients with the following specific conditions in the CMMI ACCESS clinical use areas:

• Early cardiorenal metabolic: hypertension, dyslipidemia, obesity or overweight with central obesity markers, or prediabetes;
• Cardiorenal metabolic: diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease;
• Musculoskeletal: chronic musculoskeletal pain;
• Behavioral health: depression or anxiety.

For more information on CMMI ACCESS clinical use areas, see the ACCESS Model application guide on the CMS Innovation Center website or contact CMS at ACCESSModelTeam@cms.hhs.gov.

Q8: Does TEMPO require participation in CMMI ACCESS? Through the TEMPO pilot, a manufacturer may request that FDA exercise enforcement discretion and not enforce certain applicable requirements when its device is furnished or used by CMMI ACCESS participants, provided the device is intended to improve patient outcomes and is used for care expected to be covered by the CMMI ACCESS Model. For example, this may include a situation in which the manufacturer itself is a participating organization under the CMMI ACCESS Model, or the manufacturer supplies the device to other participants under the CMMI ACCESS Model for use to improve patient outcomes.

Q9: Can a device in the TEMPO pilot be marketed for the same intended use outside the CMMI ACCESS Model? No. Through the TEMPO pilot, a manufacturer may request that FDA exercise enforcement discretion and not enforce certain applicable requirements when the device is furnished or used by CMMI ACCESS participants, provided the device is intended to improve patient outcomes and is used for care expected to be covered by the CMMI ACCESS Model. Furnishing the device in other circumstances, such as outside the CMMI ACCESS Model, is outside the scope of the TEMPO pilot. Generally, if a digital health device manufacturer wishes to offer a device for an intended use to improve patient outcomes, the device must receive FDA authorization for that use.

Q10: Are devices in the TEMPO pilot expected to obtain FDA authorization? Although FDA may exercise enforcement discretion and not enforce premarket authorization requirements during pilot participation, FDA expects participating manufacturers to ultimately seek appropriate FDA marketing authorization using data collected during the pilot and other information supporting a marketing submission. FDA expects to discuss proposed timelines for submitting a 510(k) or other type of marketing submission with participants.

Q11: Does FDA expect pilot sites to obtain IRB approval? Manufacturers interested in participating in the TEMPO pilot may request that FDA exercise enforcement discretion for certain applicable requirements. Such requirements may include requirements under 21 CFR Part 50 (informed consent) and Part 56 (institutional review boards). FDA will work with TEMPO pilot participants to determine the circumstances in which enforcement discretion applies to the manufacturer's device.

Letters of Intent

Q12: Is there a submission deadline for letters of intent? FDA has not set a deadline to stop accepting letters of intent to participate in the TEMPO pilot. However, because TEMPO is a pilot, FDA plans to limit participation and currently expects to select up to about ten US-based manufacturers in each identified clinical use area. FDA began accepting letters of intent on January 2, 2026, and in March 2026 began sending follow-up requests to certain potential pilot participants reflecting a broad range of manufacturers. FDA continues to consider letters of intent and plans to continue sending follow-up requests to certain potential participants.

Q13: Is there a specific template for the letter of intent? A letter of intent to participate in the TEMPO pilot should be titled Letter of Intent to Participate in the TEMPO Pilot and submitted by email to FDA-TEMPOPilot@fda.hhs.gov. The letter of intent should identify the manufacturer and its device, including any existing authorization or prior FDA interaction related to the device, such as relevant submission numbers; include a proposed indication statement identifying the intended use to improve patient outcomes consistent with participation in the CMMI ACCESS program; and request that FDA provide the manufacturer with a statement that FDA does not intend to enforce certain legal requirements, such as premarket authorization requirements, investigational device exemption requirements, and requirements under 21 CFR Parts 50 and 56.

Q14: What should a letter of intent include? A letter of intent should include:

• Identification of the manufacturer and its device, including any existing authorization or prior FDA interaction related to the device, such as relevant submission numbers;
• A proposed indication statement identifying the intended use to improve patient outcomes consistent with participation in the CMMI ACCESS program;
• A request that FDA exercise enforcement discretion for certain legal requirements.

Manufacturers may choose to include additional information in the letter of intent, such as a brief description of the maturity of the manufacturer's quality management system or a summary of information supporting device safety. However, such information is not required at the letter of intent stage.

Q15: Are there document size limits or format requirements for letters of intent? In the TEMPO pilot, there are no size or format rules for how information is provided to FDA, such as PDF, slides, or other document types. However, the total size of an email and attachments accepted by the TEMPO pilot mailbox at FDA-TEMPOPilot@fda.hhs.gov is limited to 150 MB. If the email and attachments, separately or combined, exceed 150 MB, please try to split them into smaller separate emails and attachments. Manufacturers interested in participating in the TEMPO pilot should ensure that the information provided contains sufficient detail to inform FDA's evaluation, is in a format that facilitates clear assessment of the information provided, and is in English. Letters of intent should be sent by email to FDA-TEMPOPilot@fda.hhs.gov.

Selection

Q16: How will FDA evaluate and select participants? After receiving letters of intent to participate in the TEMPO pilot, FDA will send follow-up requests to certain potential pilot participants reflecting a broad range of manufacturers for additional information. The Federal Register notice identifies certain types of information that may help potential pilot participants provide information to the agency. FDA intends to consider this information in evaluating and selecting TEMPO pilot participants.

FDA intends to select TEMPO pilot participants based on the strategic goals of the pilot, which are to promote patient access, safeguard patient safety, and generate meaningful real-world data related to the CMMI ACCESS Model. Factors FDA intends to consider include but are not limited to: potential risk to patient health, safety, or welfare; whether there is a reasonable expectation that the device can provide patient benefit; the RWD collection, monitoring, analysis, and reporting plan; and alignment with outcomes to be measured in the CMMI ACCESS Model.

Q17: When will FDA begin follow-up communications with potential TEMPO pilot participants? FDA began sending follow-up requests to certain potential pilot participants in March 2026 for additional information to help FDA make participation decisions. FDA continues to consider letters of intent and plans to continue sending follow-up requests to certain potential participants.

Q18: What additional information might FDA request from potential TEMPO pilot participants? After receiving letters of intent, FDA will send follow-up requests to certain potential pilot participants for additional information. The types of information that may be helpful vary by device, but the following general types of information may be useful:

• A device description, including proposed indications and claims, clearly describing the intended use to improve patient outcomes that the manufacturer wishes to offer in connection with the CMMI ACCESS Model;
• Data to demonstrate that the device is sufficiently safe and performs as designed and to support a reasonable expectation that the device can provide patient benefit, such as a reference list, copies of publications, and summaries of unpublished information related to device safety assessment and support for a reasonable expectation of patient benefit;
• Information about the manufacturer's quality management system;
• A plan to adequately mitigate patient risk and provide for real-world performance data collection, monitoring, analysis, and reporting;
• Proposed performance goals and a statistical analysis plan for patient outcomes;
• A proposed timeline for data collection and submission to FDA of a premarket notification 510(k) or other type of marketing submission, as applicable, for the intended use for which the manufacturer would offer the device in connection with the CMMI ACCESS Model;
• A proposed interim reporting plan, including frequency such as every six months, to report adverse events, new risks, and progress against the timeline.

Q19: Is a compliant quality management system required to participate in the TEMPO pilot? In the Federal Register notice announcing the TEMPO pilot, FDA stated that it will send follow-up requests to certain potential pilot participants for additional information and noted that the types of information that may be helpful include information about the manufacturer's quality management system. FDA expects this information may help clarify the scope of the manufacturer's request for enforcement discretion, for example, whether the manufacturer is fully compliant with FDA's Quality Management System Regulation or is not compliant with the QMSR in whole or in part and is requesting that FDA not enforce certain applicable QMSR requirements during the manufacturer's potential participation in the TEMPO pilot. Generally, during pilot participation, a manufacturer should have a compliant QMS to help ensure patient safety. FDA will work with TEMPO pilot participants to determine the circumstances in which enforcement discretion applies to the manufacturer's device. For manufacturers seeking to participate in the FDA TEMPO pilot, FDA does not intend to require detailed QMS documentation during the evaluation and selection of TEMPO pilot participants. Please note that FDA generally expects all TEMPO pilot participants to register and list their devices.

Q20: Which manufacturers has FDA selected to participate in the TEMPO pilot? In July 2026, FDA announced the first selected participant in the TEMPO pilot. For more information, visit the TEMPO pilot participants webpage. FDA intends to update the webpage as additional TEMPO pilot participants are selected.

What This Means for Medical Device Companies

Information of this type published by FDA CDRH News and Updates should first be incorporated by companies into regulatory intelligence and post-market monitoring, rather than treated only as general news. Companies need to determine whether the update is a guidance document, recall safety information, product approval, digital health information, quality system information, or post-market regulatory information, and confirm whether it may affect existing registration projects or products under development.

If the content involves specific products, testing performance, risk warnings, or regulatory measures, companies should further assess whether it affects product classification, the 510(k), De Novo, or PMA pathway, technical files, labeling and instructions for use, quality system records, or post-market reporting obligations. For companies advancing US market registration, the source link, publication date, scope of application, and internal assessment conclusions should be recorded in the project tracker.

What Companies Should Check

• Basis for product classification;
• Applicable regulatory provisions;
• Predicate device or equivalence assessment;
• Performance testing;
• Software and cybersecurity documentation;
• Risk management;
• Clinical evidence;
• Labeling and instructions for use;
• Quality management system readiness.

Common Risks

Common risks include misjudging the FDA pathway, overlooking changes in guidance documents, insufficient performance test design, overly broad labeling claims, unclear post-market reporting obligations, and directly applying materials from other markets to US registration.

AIMEILI Insight

AIMEILI Regulatory Interpretation

AIMEILI regulatory interpretation: The TEMPO Digital Health Device Pilot is an important collaborative innovation between FDA and CMS in chronic disease management. It uses enforcement discretion as a lever to accelerate access for certain digital health devices in a Medicare payment environment. For Chinese digital health device companies, although the pilot expressly requires manufacturers to be located in the United States, the model sends a strong signal that FDA is exploring risk-based, more flexible regulatory pathways, especially for software-based medical devices intended to improve patient outcomes.

From a registration pathway perspective, the TEMPO pilot provides a conditional exemption route for digital health devices that have not yet received FDA authorization, allowing them to avoid immediate 510(k) or PMA submission while used under the CMMI ACCESS Model. This is not a permanent exemption. FDA clearly expects companies to use real-world evidence collected during the pilot to ultimately seek marketing authorization. Companies planning to use this route to bring products to the US market should design a real-world data collection strategy from the outset and complete the transition from exemption to formal authorization within the limited pilot period.

For product classification and scope of application, the pilot is expressly limited to four clinical areas, namely early cardiorenal metabolic, cardiorenal metabolic, musculoskeletal, and behavioral health, and to specific conditions. Chinese companies assessing whether their products match should carefully verify their indication descriptions. For example, hypertension falls under early cardiorenal metabolic, while diabetes falls under cardiorenal metabolic. If a product's indications span multiple areas, FDA allows a single device to cover multiple uses, but the intended use must clearly state them. This may require more precise definition of intended-use statements in technical files.

For technical files and performance validation, FDA requires participants to provide data demonstrating device safety, functional performance, and support for a reasonable expectation of patient benefit. Although some premarket requirements may be subject to enforcement discretion during the pilot, clinical trials or equivalent performance data remain central to demonstrating safety. Companies should prepare scientific literature, laboratory test results, or real-world data in advance so they can respond quickly when FDA requests additional information. It is noteworthy that FDA may request quality management system information but does not intend to require detailed QMS documents during the evaluation stage; however, compliance should be maintained after formal participation.

Labeling requirements are not waived by the TEMPO pilot. Device labeling must still comply with 21 CFR Part 801 and other applicable requirements, including clear instructions for use and risk information. Devices participating in the pilot may need labeling that notes the relationship between their intended use and the CMMI ACCESS Model. This is a special situation in international registration, and companies should work with professional advisors to ensure labeling meets the expectations of all parties.

For the quality system, although FDA may exercise enforcement discretion for certain QMSR requirements, participating companies are generally expected to have a compliant quality management system. For Chinese companies that have not yet established a compliant QMS and plan to participate through a US subsidiary or partner, they should ensure that the US entity has a system meeting FDA QMSR requirements, which are based on ISO 13485, and that relevant records are stored at a US FDA-registered facility. This involves transfer and localization of quality documents.

At the post-market maintenance level, the TEMPO pilot places particular emphasis on real-world data collection, monitoring, analysis, and periodic reporting, such as every six months. This means that the post-market regulatory burden for participating companies may not be lighter than the traditional pathway; it may increase costs because of the need to submit interim reports to FDA on an ongoing basis. Companies should establish a dedicated data team or engage a CRO to manage RWD.

Overall, the TEMPO pilot opens an experimental fast track for digital health devices, but the threshold is not low. When considering this route, Chinese companies should first assess US entity establishment, data strategy, clinical evidence preparation, and quality system compliance capabilities, and work with professional advisors experienced in FDA regulation to maximize the time advantage created by enforcement discretion while avoiding loss of pilot eligibility or obstacles in subsequent applications due to insufficient preparation.

Business Impact

• US presence: Non-US manufacturers need a US domestic entity with a US federal tax identification number and US-stored QMS records at an FDA-registered facility, or a suitable US partner structure.
• Portfolio selection: Prioritize finished devices in the four ACCESS areas with clear outcome claims and low serious risk.
• Data and evidence: Build RWD collection, monitoring, analysis, and reporting capabilities, and plan interim reports and statistical analysis.
• Regulatory transition: Budget for eventual 510(k), De Novo, or PMA submission and align pilot data with the marketing submission.
• QMS and labeling: Prepare QMSR-compliant systems, US records, and labeling compliant with 21 CFR Part 801 and ACCESS-linked use statements.
• Post-market burden: Allocate resources for periodic reporting and adverse event monitoring.

Additional FAQ

Clear professional answer: An FDA public page update does not by itself necessarily indicate a regulatory change. Companies should classify the update and verify it against the FDA source and applicable regulations before changing project plans.

Does an FDA public page update always represent a regulatory change? Not necessarily. It is necessary to distinguish news, guidance, database pages, recall information, and formal regulatory documents. Important content should be verified against the original FDA source and applicable regulations.

What should companies do after seeing an FDA update? Companies should first determine whether it affects product classification, registration pathway, technical files, or post-market obligations, and then decide whether to update project plans.

Content Review and Applicability Boundaries

• Content author: AIMEILI Regulatory Editorial Team
• Professional review: AIMEILI International Medical Device Registration Project Team
• Source principle: Priority is given to official regulatory authorities, international organizations, standards organizations, and public regulatory materials. Industry media and project experience are used only as supporting judgment.
• Applicability boundary: This article is intended for preliminary understanding, document preparation, and project planning. It does not replace the official requirements of target-country regulatory authorities, testing conclusions, or legal opinions.

Related Updates

• July 22, 2026: FDA Announces First Selected Participant in TEMPO Digital Health Device Pilot
• July 3, 2026: European Commission Publishes Documents Related to Medical Device Market Supply Monitoring Study
• July 7, 2026: ANSM Publishes Safety Information on Sener Diagnostics Autoplak Advance Automated Equipment
• July 7, 2026: ANSM Publishes Safety Information on bioMerieux Argene Enterovirus R-GENE Reagent
• July 9, 2026: TGA Flags Performance Concerns for TouchBio Chlamydia and Gonorrhea Self-Test Products
• July 9, 2026: ANSM Publishes Recall Notice for Boston Scientific Rapid Refill Continuous Injection System

Contact AIMEILI

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