Notice2025-22190
Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
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Published
December 8, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is announcing its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot ("TEMPO pilot"), in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety.
Full Text
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<title>Federal Register, Volume 90 Issue 233 (Monday, December 8, 2025)</title>
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[Federal Register Volume 90, Number 233 (Monday, December 8, 2025)]
[Notices]
[Pages 56768-56770]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22190]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6461]
Technology-Enabled Meaningful Patient Outcomes (TEMPO) for
Digital Health Devices Pilot
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA's) Center for Devices
and Radiological Health (CDRH) is announcing its Technology-Enabled
Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
(``TEMPO pilot''), in connection with the Center for Medicare and
Medicaid Innovation (CMMI) Advancing Chronic Care with Effective,
Scalable Solutions (ACCESS) model, to promote access to certain digital
health devices while safeguarding patient safety.
DATES: FDA is seeking statements of interest for participation in the
TEMPO pilot beginning January 2, 2026. See below for instructions on
how to submit a statement of interest for participation in the TEMPO
pilot.
FOR FURTHER INFORMATION CONTACT: Jessica Paulsen, Center for Devices
and Radiological Health, Food and Drug Administration, 301-796-6883,
<a href="/cdn-cgi/l/email-protection#99dfddd8b4cddcd4c9d6c9f0f5f6edd9fffdf8b7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="561012177b02131b0619063f3a392216303237783e3e2578313920">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. TEMPO Pilot
FDA is announcing its TEMPO pilot, in connection with the CMMI
ACCESS model (Ref. 1), to promote access to certain digital health
devices while safeguarding patient safety. Through the CMMI ACCESS
model, the Centers for Medicare and Medicaid Services (CMS) will test a
new payment option that emphasizes patient outcomes, enabling
clinicians to offer innovative technology-supported care to improve
patients' health and prevent and manage chronic disease (Ref. 1). The
CMMI ACCESS model introduces Outcome-Aligned Payments, which are
recurring payments for managing a patient's qualifying condition, with
payment tied to achieving measurable health outcomes (Ref. 1). CMS has
designed the CMMI ACCESS model to include several safeguards to support
clinical quality and accountability; under the CMMI ACCESS model, CMS
will monitor performance and may terminate organizations who fail to
meet quality, safety, or outcome standards, and will publish risk-
adjusted outcomes in a public directory (Ref. 1).
In general, if the manufacturer of a digital health device wishes
to offer its device for an intended use to improve patient outcomes
(e.g., measurable changes in chronic disease outcomes), the device
must, among other things, be authorized by FDA for that use. If a
manufacturer seeks to offer its device for an intended use to improve
patient outcomes such that it may be used to provide care covered by
the CMMI ACCESS model, FDA generally expects the device to be FDA-
authorized for that use. However, manufacturers of certain digital
health devices that are not already authorized by FDA for such use may
request to participate in FDA's TEMPO pilot by following the procedures
described in this notice and requesting that FDA exercise enforcement
discretion and not enforce certain applicable requirements when their
device is offered to or by CMMI ACCESS participants \1\ for an intended
use to improve patient outcomes, to be used in providing care expected
to be covered by the CMMI ACCESS model. For example, such manufacturers
might request that FDA exercise enforcement discretion and not enforce
premarket authorization requirements, investigational device exemption
(IDE) requirements, requirements under 21 CFR parts 50 and 56, or other
applicable requirements. As is often the case when FDA exercises
enforcement discretion and informs a manufacturer that FDA does not
intend to enforce certain applicable requirements, FDA will work with
participants in the TEMPO pilot to identify the circumstances when
enforcement discretion may be appropriate for that manufacturer's
device, including, for example, when the labeling includes appropriate
cautions, and when FDA requests that certain records be maintained (as
may
[[Page 56769]]
be informed by certain types of documentation described in 21 CFR
812.140 and 812.150).
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\1\ 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.
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FDA recognizes that real-world data (RWD) may be collected in the
course of clinical practice during the treatment and management of
patients, particularly with the use of digital health devices. Under
certain circumstances, RWD may be used to generate real-world evidence
(RWE) that can help inform or augment FDA's understanding of the
benefit-risk profile of devices at various points in their life cycle.
These data may also be supportive of FDA's review of devices, along
with other information needed in a marketing submission. FDA expects
that manufacturers participating in the TEMPO pilot will collect RWD
relating to the intended uses of their devices to improve patient
outcomes while offering the devices for use in providing care covered
by the CMMI ACCESS model, share the data with FDA during their
participation in the TEMPO pilot, and, using the data collected during
their participation in the TEMPO pilot (along with other information),
seek appropriate marketing authorization from FDA.
As the TEMPO pilot is a pilot, FDA plans to limit participation,
and currently expects to select up to about ten manufacturers based in
the United States \2\ in each of the four clinical use areas identified
in this notice (see below). To further help us gain insights, we hope
to have broad representation among participants, with manufacturers of
all sizes, types, and maturities.
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\2\ FDA intends to select manufacturers based in the United
States for participation in the TEMPO pilot to facilitate FDA's
oversight of participating manufacturers, for example, to facilitate
inspections and/or access to records.
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In selecting participants, FDA intends to evaluate whether the
digital health device would not present a potential for serious risk to
the health, safety, or welfare of patients. Given the nature of the
pilot, FDA will select digital health products that meet the definition
of a device in section 201(h) of the Federal Food, Drug, and Cosmetic
(FD&C) Act (21 U.S.C. 321(h)) (including those that are artificial-
intelligence-enabled), and are intended to be used in conjunction with
clinician-supervised outpatient treatment to patients with conditions
in one of the following four CMMI ACCESS clinical use areas: early
cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or
overweight with marker of central obesity, or prediabetes), cardio-
kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic
cardiovascular disease), musculoskeletal (chronic musculoskeletal
pain), or behavioral health (depression or anxiety). These digital
health devices may rely on off-the-shelf platforms such as general-
purpose computing platforms or wearable products (that may or may not
be regulated wearable devices).
To request to participate in the TEMPO pilot, a manufacturer should
contact FDA at <a href="/cdn-cgi/l/email-protection#da9c9e9bf78e9f978a958ab3b6b5ae9abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="1c5a585d314859514c534c757073685c7a787d3274746f327b736a">[email protected]</span></a>. This communication should be
titled ``Statement of Interest for Participation in the TEMPO Pilot,''
and 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 FDA give the
manufacturer a statement that FDA does not intend to enforce certain
legal requirements (e.g., a statement that FDA does not intend to
enforce premarket authorization requirements, IDE requirements, and
requirements under 21 CFR parts 50 and 56). FDA will collect statements
of interest for participation in the TEMPO pilot beginning [January 2,
2026]. Upon receipt of the statement of interest, FDA will follow up
with certain potential pilot participants who reflect a broad spectrum
of manufacturers to request additional information to help enable FDA
to make a decision concerning participation. FDA expects to begin to
send follow-up requests around [March 2, 2026]. 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.
FDA will inform manufacturers who have submitted a statement of
interest about FDA's decision. As part of the TEMPO pilot, FDA will
offer and encourage pilot participants to engage in ``sprint''
discussions with the goal of reaching mutual agreement on a specific
topic within a set time period (e.g., 45 days) that may relate to the
planned marketing submission.\3\ The number, format, and duration of
interactions within a sprint discussion may vary based on project
needs. Although data collected during participation in the TEMPO pilot
are intended to be supportive of a marketing submission to FDA,
additional data may also be needed to support a marketing submission.
Participation in the TEMPO pilot is not an indication of whether FDA
will issue a positive decision for any future marketing submission.
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\3\ For additional information regarding sprint discussions, see
Section IV.A of FDA's guidance document entitled ``Breakthrough
Devices Program; Guidance for Industry and Food and Drug
Administration Staff,'' September 15, 2023, available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program</a>.
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II. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in FDA regulations. The previously approved
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). The collections of information in 21 CFR part
820 (Quality System Regulation) and relating to device master files
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 812 (Investigational Device Exemptions)
[[Page 56770]]
have been approved under OMB control number 0910-0078; the collections
of information in part 807, subpart E (Premarket Notification
Procedures), have been approved under OMB control number 0910-0120; the
collections of information under 21 CFR part 801 (Device Labeling) have
been approved under OMB control number 0910-0485; and the collections
of information in 21 CFR 860, subpart D (De Novo Classification) have
been approved under OMB control number 0910-0844.
III. References
The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and is available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
it is also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
1. CMS, ``ACCESS (Advancing Chronic Care with Effective, Scalable
Solutions) Model,'' available at <a href="https://www.cms.gov/priorities/innovation/innovation-models/access">https://www.cms.gov/priorities/innovation/innovation-models/access</a> (last accessed on December 1,
2025).
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22190 Filed 12-5-25; 8:45 am]
BILLING CODE 4164-01-P
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