FDA & TEMPO Compliance
Participating in the ACCESS Model requires understanding FDA requirements for digital health technologies. This guide covers regulatory pathways, the TEMPO pilot program, and compliance considerations for ACCESS participants.
Key Requirement
ACCESS participants are responsible for ensuring that medical devices used in the model are legally marketed with an intended use for which the device is used in the model — appropriately cleared, approved, 510(k)-exempt, or otherwise in compliance with applicable FDA requirements.
Understanding FDA Device Regulation
Some digital tools and connected devices used in ACCESS — such as mobile applications, wearables, or remote monitoring equipment — may meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) if they are:
- Intended for use in the diagnosis of disease or other conditions
- Intended for the cure, mitigation, treatment, or prevention of disease
- Intended to affect the structure or any function of the body
These devices are generally subject to FDA oversight to provide reasonable assurance of safety and effectiveness.
What Requires FDA Authorization?
| Category | FDA Status | Examples |
|---|---|---|
| FDA-Cleared/Approved Devices | Requires 510(k) clearance or PMA approval | Blood pressure monitors, glucose monitors, certain diagnostic software |
| 510(k)-Exempt Devices | Low-risk, exempt from premarket review | Some Class I devices, certain exercise equipment |
| Enforcement Discretion | FDA chooses not to enforce requirements | Certain wellness apps, some clinical decision support |
| Not Regulated as Devices | Falls outside device definition | General wellness apps, administrative software, data storage |
Software as a Medical Device (SaMD)
Software intended to be used for medical purposes that performs these purposes without being part of a hardware medical device is classified as Software as a Medical Device (SaMD). This includes:
- Diagnostic algorithms
- AI/ML-based clinical decision support
- Remote patient monitoring software
- Digital therapeutics
Important Distinction
The intended use of your software determines its regulatory status. Software that makes clinical recommendations may be regulated differently than software that simply displays data.
The TEMPO Pilot Program
The Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot is an FDA initiative launched in connection with the ACCESS Model to promote access to certain digital health devices while safeguarding patient safety.
What is TEMPO?
TEMPO allows manufacturers of certain digital health devices that are not yet FDA-authorized for a specific intended use to request that FDA exercise enforcement discretion. This means FDA will not enforce certain premarket authorization requirements when the device is offered to or by ACCESS participants for an intended use to improve patient outcomes.
TEMPO Benefit
TEMPO enables innovative digital health devices to be used in the ACCESS Model while collecting real-world data that may support future FDA marketing submissions.
How TEMPO Works
Statement of Interest
Manufacturers submit a statement of interest to FDA expressing desire to participate in the TEMPO pilot.
FDA Follow-Up
FDA reviews submissions and sends follow-up requests to certain potential participants to discuss their device and intended use.
Risk Mitigation Plan
FDA works with manufacturers to identify circumstances where enforcement discretion is appropriate, including labeling requirements and record-keeping.
Real-World Data Collection
Manufacturers collect real-world data relating to device performance and patient outcomes during ACCESS participation.
Marketing Authorization
Using collected data, manufacturers seek appropriate FDA marketing authorization for their device.
TEMPO Timeline
January 2, 2026
TEMPO Opens
FDA begins collecting statements of interest for participation in the TEMPO pilot
March 2, 2026
Follow-Up Begins
FDA expects to begin sending follow-up requests to certain potential pilot participants
TEMPO Requirements for ACCESS Participants
If you choose to use a device participating in the TEMPO pilot, you must:
- Obtain enhanced consent from enrolled beneficiaries
- Inform patients that the device is participating in an FDA pilot
- Disclose that certain data will be shared with FDA
- Comply with all applicable federal privacy and security requirements
- Follow any risk mitigation plan discussed between the manufacturer and FDA
TEMPO is Optional
Participation in the TEMPO pilot is voluntary. ACCESS participants can use FDA-authorized devices without participating in TEMPO.
FDA Digital Health Categories
Regulated as Medical Devices
These require FDA clearance, approval, or fall under enforcement discretion:
- Remote patient monitoring devices — Blood pressure cuffs, glucose monitors, pulse oximeters
- Diagnostic software — AI algorithms that diagnose conditions
- Digital therapeutics — Software that treats or manages disease
- Clinical decision support — Software that provides patient-specific recommendations
Generally Not Regulated
These typically fall outside FDA device regulation:
- General wellness products — Apps that encourage healthy lifestyle choices
- Administrative software — Scheduling, billing, practice management
- Electronic health records — Basic EHR functionality
- Data storage and transfer — HIPAA-compliant data management
Enforcement Discretion Categories
FDA has stated it does not intend to enforce requirements for certain software functions:
- Software for maintaining or encouraging a healthy lifestyle (unrelated to disease)
- Software that serves as electronic patient portals
- Software for health care provider communication
- Certain clinical decision support software that meets specific criteria
Compliance Checklist for ACCESS Participants
Inventory Your Technology
Create a comprehensive list of all digital tools, software, and devices you plan to use in ACCESS care delivery.
Determine Regulatory Status
For each technology, determine whether it is FDA-cleared/approved, 510(k)-exempt, subject to enforcement discretion, or not regulated as a device.
Verify Intended Use Alignment
Ensure the intended use for which the device is FDA-authorized matches how you plan to use it in ACCESS.
Document Your Analysis
Maintain written documentation of your regulatory analysis for each technology.
Monitor for Updates
Stay informed about FDA guidance updates and changes to device clearance status.
AI/ML in Medical Devices
Artificial Intelligence and Machine Learning (AI/ML) technologies are increasingly used in medical devices, including Software as a Medical Device. FDA has specific guidance for these technologies.
Key Considerations
- Predetermined Change Control Plans — For devices that learn and adapt over time
- Good Machine Learning Practice (GMLP) — FDA's framework for AI/ML device development
- Transparency — Requirements for explaining AI/ML-based recommendations to clinicians
- Continuous learning — How to handle devices that update their algorithms
FDA AI/ML in Medical Devices
FDA guidance on AI and machine learning in Software as a Medical Device
FDA Resources
Digital Health Center of Excellence
FDA Digital Health Center of Excellence
FDA's hub for digital health technologies, including SaMD, AI/ML, cybersecurity, and more
Guidance Documents
FDA Guidances with Digital Health Content
Complete list of FDA guidance documents relevant to digital health
Device Software Functions
FDA policy on device software functions including mobile medical applications
Interactive Tools
Digital Health Policy Navigator
Interactive tool to help understand which FDA policies apply to your digital health product
Frequently Asked Questions
Do all digital health tools used in ACCESS need FDA clearance?▼
No. The requirement depends on the intended use and risk level of the technology. FDA-authorized devices must have appropriate clearance for the intended use. Some software falls under FDA enforcement discretion, and general wellness apps or certain clinical decision support may not require authorization. You must document your regulatory analysis for each technology you use.
What is the difference between 510(k) clearance and PMA approval?▼
510(k) clearance is for devices that are substantially equivalent to a legally marketed device (predicate). Most medium-risk devices use this pathway. PMA (Premarket Approval) is for high-risk devices (Class III) and requires clinical evidence of safety and effectiveness. PMA is more rigorous and typically takes longer.
Can clinicians use FDA-cleared devices for off-label purposes in ACCESS?▼
ACCESS does not change existing FDA policies regarding the practice of medicine, including a clinician's ability to exercise professional judgment. However, for ACCESS billing purposes, devices should generally be used consistent with their cleared intended use.
Is TEMPO participation required to use digital health devices in ACCESS?▼
No. TEMPO is specifically for manufacturers of devices that are not yet FDA-authorized for a particular intended use. If your devices are already FDA-cleared/approved for your intended use, you do not need TEMPO participation.
How do I know if my software is considered a medical device?▼
The FDA's Digital Health Policy Navigator can help you determine if your software is regulated as a medical device. Key factors include the intended use, whether it makes clinical recommendations, and the level of risk to patients. When in doubt, consult with FDA or a regulatory expert.
What records should I maintain for FDA compliance?▼
Maintain documentation of: (1) regulatory status determination for each device/software, (2) FDA clearance/approval letters for authorized devices, (3) intended use statements, (4) any correspondence with FDA, and (5) quality management system records as applicable.
Contact & Support
FDA Digital Health Center of Excellence
- Ask a Question: Submit regulatory policy questions through the FDA website
- Network of Experts: Connect with FDA's digital health specialists
ACCESS Model Team
- Email: ACCESSModelTeam@cms.hhs.gov
Next Steps
Technical Requirements
Review technology infrastructure requirements for ACCESS participation
Official Documents
Download the RFA and other official ACCESS materials
Check Eligibility
Review all requirements to participate in ACCESS