What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers

By Brynn Stanley

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the FDA Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Digital Health Devices and the CMS Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model. Together, they create new opportunities and new compliance expectations for medical device and digital health companies. Although both programs are voluntary, they introduce frameworks that could meaningfully reshape how device technologies reach patients, how evidence is generated, and how reimbursement pathways evolve.

Manufacturers that develop digital health tools, remote monitoring technologies, chronic-condition devices, or software-based interventions should pay close attention as these models roll out.

FDA TEMPO Pilot: Regulatory Flexibility Paired with Real-World Controls

FDA’s TEMPO Pilot is a first-of-its-kind effort that allows manufacturers of certain digital health devices to request FDA enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, under a risk-based enforcement discretion model. Under this model, manufacturers collect real-world evidence (RWE) under FDA-defined guardrails to demonstrate device performance.

FDA TEMPO Pilot: Required Submission Elements

To participate in TEMPO, manufacturers must submit a statement of interest and a supporting package that enables FDA to assess safety, readiness, and planned RWE generation. Required components include:

1. Device Description & Intended Use

• Description of the device, proposed indications for use, and proposed claims describing the intended outcome-improving use within the CMS ACCESS Model

2. Evidence of Safety and Expected Patient Benefit

• Data demonstrating the device is adequately safe and functions as designed
• Evidence supporting a reasonable expectation of patient benefit (e.g., bibliography, publications, and summaries of relevant unpublished data)

3. Quality Management System (QMS) Information

• Documentation sufficient to show the manufacturer has a capable QMS to support real-world deployment and monitoring

4. Risk-Mitigation and Real-World Data Plan

• A plan detailing how risks will be mitigated and how real-world performance data will be collected, monitored, analyzed, and reported

5. Performance Goals & Statistical Analysis Plan

• Proposed performance goals and a statistical plan for evaluating patient outcomes

6. Timeline to Marketing Submission

• A projected timeline for data collection and submission of a 510(k), De Novo, or other marketing submission for the intended use aligned with the ACCESS Model

7. Interim Reporting Plan

• Proposed reporting frequency (e.g., every 6 months) covering adverse events, new risks, and progress against milestones

CMS ACCESS Model: A Reimbursement On-Ramp for Technology-Enabled Care

CMS’s ACCESS Model is a 10-year Innovation Center initiative designed to reimburse providers for technology-enabled chronic-care management, including remote monitoring, behavioral-health support, and digitally assisted care pathways.

FDA designed TEMPO specifically to complement ACCESS and allow devices deployed under TEMPO to be leveraged in ACCESS-participating care models.

CMS ACCESS Model: Required Participation Elements

While ACCESS is a provider-focused payment model, manufacturers supporting technology-enabled care within the model must be prepared to supply information and capabilities that allow providers to participate successfully. Relevant manufacturer deliverables include:

1. Technology Description & Intended Clinical Use

• Participation in the program must be in alignment with ACCESS’s targeted conditions
  • Early cardio-kidney-metabolic conditions (eCKM): hypertension (high blood pressure), dyslipidemia (high or abnormal lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
  • Cardio-kidney-metabolic conditions (CKM): diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease
  • Musculoskeletal conditions (MSK): chronic musculoskeletal pain
  • Behavioral health conditions (BH): depression and anxiety

2. Clinical and Real-World Evidence Supporting Use

• Evidence demonstrating the technology’s ability to improve outcomes and support ACCESS’s value-based aims.

3. Interoperability & Integration Information

• Documentation showing the device can integrate into care-management workflows, EHR systems, and data-exchange platforms.

4. Data Collection & Reporting Capabilities

• Information detailing how the device captures, stores, transmits, and reports patient-level data to support provider obligations under ACCESS.

5. Safety, Usability, and Risk-Mitigation Information

• Evidence and documentation supporting safe deployment in routine clinical settings, including instructions for use and corrective action procedures.

6. Regulatory & Compliance

• Participating organizations must enroll in Medicare Part B as suppliers and comply with applicable state licensure requirements and Health Insurance Portability and Accountability Act of 1996 (HIPAA) and FDA requirements (or otherwise be subject to FDA enforcement discretion).

What These Programs Mean for Manufacturers

Together, TEMPO and ACCESS create the strongest structural signal to date that FDA and CMS are coordinating to accelerate digital health adoption.

The programs create a coordinated pathway for device manufacturers to bring digital health and chronic-care technologies into real-world use earlier while generating the evidence needed for long-term regulatory and reimbursement success. TEMPO offers an FDA-supervised, discretionary enforcement environment to collect structured, real-world performance data, while ACCESS provides a CMS payment model that rewards technology-enabled care. For manufacturers, these programs enable faster market entry, clearer evidence expectations, and a more direct bridge between regulatory strategy and Medicare adoption.

How Gardner Law Can Help

Manufacturers considering participation in TEMPO or supporting care models under ACCESS should act now. These programs require early alignment across regulatory strategy, evidence generation, quality systems, and reimbursement planning, well before products reach traditional clearance or coverage milestones.

Gardner Law advises medical device and digital health companies on navigating FDA enforcement discretion programs, real-world evidence strategies, quality system readiness, and CMS reimbursement considerations. We help clients assess eligibility, structure statements of interest with supporting documentation packages and evidence plans, manage compliance risk during real-world deployment, and align regulatory and commercialization strategies across FDA and CMS. As these pilots evolve, early, well-structured participation will be critical to realizing their full regulatory and reimbursement potential.

The FDA began taking statements of interest January 2, 2026.