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TEMPO for Digital Health Devices Pilot Frequently Asked Questions

The FDA launched the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. The TEMPO pilot aims to:

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

Through the TEMPO pilot, a manufacturer may request that the FDA exercise enforcement discretion for certain requirements when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model. The FDA will work with participants to identify the circumstances when enforcement discretion may be appropriate for that manufacturer's device.

Key dates:

  • January 2, 2026: The FDA began receiving statements of interest for participation in the TEMPO pilot.
  • Around March 2, 2026: The FDA will begin sending follow up requests to certain potential pilot participants to request additional information to help enable the FDA to make a decision concerning participation.

For more information about the TEMPO pilot and how to submit a statement of interest, refer to the Federal Register notice. To learn more about the CMMI ACCESS model, visit the Centers for Medicare and Medicaid Services website.

FDA educational module on TEMPO pilot available. Learn about the goals and features of the pilot, information to include in the statement of interest for participation in the pilot, and the selection process for the pilot.The presentation, printable slides, and transcript are available on CDRH Learn under “Specialty Technical Topics,” sub-section “Digital Health.”

Frequently Asked Questions (FAQs)

The frequently asked questions (FAQs) below are intended to help manufacturers find answers to commonly asked questions about the TEMPO pilot. For other questions, please send an email to FDA-TEMPOPilot@fda.hhs.gov.

ELIGIBILITY

A. Manufacturers must be based in the United States.

The FDA will select manufacturers of digital health devices that

  • meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h));
  • are intended to be used in conjunction with clinician-supervised outpatient treatment to patients with conditions in one of the four CMMI ACCESS clinical use areas;
  • do not present potential for serious risk to patient health, safety, or welfare; and
  • have an intended use to improve patient outcomes consistent with the CMMI ACCESS program.

A: Manufacturers of certain digital health devices that are not already authorized by the FDA for an intended use to improve patient outcomes in one of the four CMMI ACCESS clinical use areas (early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal, and behavioral health) may request to participate in the TEMPO pilot.

 

The four eligible ACCESS model clinical use areas are:

  1. early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)
  2. cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
  3. musculoskeletal (chronic musculoskeletal pain)
  4. behavioral health (depression or anxiety)

A: Yes. For a manufacturer to be eligible for participation in the TEMPO pilot, the manufacturer’s device must be intended to improve patient outcomes for patients with one of the following specific conditions in one of the four CMMI ACCESS clinical use areas:

  1. early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)
  2. cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
  3. musculoskeletal (chronic musculoskeletal pain)
  4. behavioral health (depression or anxiety)

A: Through the TEMPO pilot, a manufacturer may request that the FDA exercise enforcement discretion and not enforce certain applicable requirements when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model.

This may include, for example, when the manufacturer is itself a participating organization under the CMMI ACCESS model, or when the manufacturer offers the device to other entities that are participants under the CMMI ACCESS model for an intended use to improve patient outcomes.

A: No. Through the TEMPO pilot, a manufacturer may request that the FDA exercise enforcement discretion and not enforce certain applicable requirements when the device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model. Offering the device in other contexts (e.g., outside of the CMMI ACCESS model) would fall outside of the TEMPO pilot. In general, if the manufacturer of a digital health device wishes to offer its device for an intended use to improve patient outcomes, the device must, among other things, be authorized by FDA for that use.

A: Although the FDA may exercise enforcement discretion and not enforce premarket authorization requirements for a device while participating in the pilot, the FDA expects manufacturers participating in the pilot to ultimately seek appropriate marketing authorization from the FDA, using the data collected during their participation in the pilot (along with additional information to support a marketing submission). The FDA expects to discuss proposed timelines for submission of a 510(k) or other type of marketing submission with participants.

 

A: Manufacturers who wish to participate in the TEMPO pilot may request that FDA exercise enforcement discretion and not enforce certain applicable requirements. Such requirements might include requirements under 21 CFR Parts 50 (informed consent) and 56 (institutional review boards). The FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer's device.

STATEMENT OF INTEREST

A:  There is no specified deadline for when the FDA will stop accepting statements of interest for participation in the TEMPO pilot. The FDA encourages manufacturers to submit their statements of interest before March 2, 2026.

However, as TEMPO is a pilot, the FDA plans to limit participation, and currently expects to select up to about ten manufacturers based in the United States in each of the four clinical use areas identified for the TEMPO pilot. The FDA began accepting statements of interest on January 2, 2026, and expects to begin sending follow-up requests around March 2, 2026, to certain potential pilot participants who reflect a broad spectrum of manufacturers.

 

A: Statements of interest for participation in the TEMPO pilot should be titled "Statement of Interest for Participation in the TEMPO Pilot" and should be submitted to FDA-TEMPOPilot@fda.hhs.gov. The statement should identify the manufacturer and the manufacturer’s device, including any current authorizations or prior FDA interactions (e.g., relevant submission numbers) related to the device; include a proposed indications for use statement identifying the intended use to improve patient outcomes in a clinical use area consistent with participation in the CMMI ACCESS program; and include a request that the FDA give the manufacturer a statement that FDA does not intend to enforce certain legal requirements (e.g., a statement that the FDA does not intend to enforce premarket authorization requirements, investigational device exemption (IDE) requirements, and requirements under 21 CFR parts 50 and 56).

A: The statement of interest should:

  1. identify the manufacturer and the manufacturer’s device, including any current authorizations or prior FDA interactions (e.g., relevant submission numbers) related to the device;
  2. include a proposed indications for use statement identifying the intended use to improve patient outcomes in a clinical use area consistent with participation in the CMMI ACCESS program; and
  3. include a request for FDA enforcement discretion for certain legal requirements.

Manufacturers may choose to include additional information in their statements of interest, such as a brief description of the maturity of the manufacturer’s quality management system, or a summary of information supporting the safety of the device. However, such information is not required to be included at the statement of interest phase.

A: There is no document size limit or specification for how information should be provided to the FDA (e.g., in PDF, slide, or other document types) in connection with the TEMPO pilot. However, manufacturers interested in participating in the TEMPO pilot should ensure that the information they provide includes sufficient details to inform FDA’s assessment, is formatted in a manner that allows for clear evaluation of the information provided, and is in English.

The statement of interest should be sent by email to FDA-TEMPOPilot@fda.hhs.gov.

SELECTION

 

A: Upon receipt of statements of interest for participation in the TEMPO pilot, the FDA will follow up with certain potential pilot participants who reflect a broad spectrum of manufacturers to request additional information. The Federal Register notice identified certain types of information that may be helpful for potential pilot participants to provide to the Agency. The FDA intends to consider that information in evaluating and selecting TEMPO pilot participants.

A: The FDA expects to begin sending follow-up requests to certain potential pilot participants around March 2, 2026, to request additional information to help enable the FDA to make a decision concerning participation.

A: Upon receipt of the statement of interest, the FDA will follow up with certain potential pilot participants to request additional information. The types of information that would be helpful to submit may vary depending on the specific device, but we believe the following general types of information may be helpful:

  1. A device description, including proposed indications for use and proposed claims clearly describing the intended use to improve patient outcomes for which the manufacturer wishes to offer the device in connection with the CMMI ACCESS model;
  2. Data to demonstrate the device is adequately safe and can function as designed, and to support a reasonable expectation that the device could provide patient benefit ( e.g., a bibliography and copies of publications and a summary of unpublished information relevant to an evaluation of the safety of the device, and to justifying a reasonable expectation that the device could provide patient benefit);
  3. Information about the manufacturer's quality management system;
  4. A plan that sufficiently mitigates risks to patients and provides for the collection, monitoring, analysis, and reporting of real-world performance data;
  5. Proposed performance goals and a statistical analysis plan for patient outcomes;
  6. 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 device for the intended use for which the manufacturer offers the device in connection with the CMMI ACCESS model; and
  7. A proposed interim reporting plan, including frequency (such as every 6 months), to report (for example) adverse events, new risks, and progress with respect to timelines.

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