FDA Requirements

ACCESS Model participants using medical devices, software, or digital health tools must comply with applicable FDA requirements. This guide explains what you need to know about FDA compliance for technology-supported care.

Key Principle

Organizations must use FDA-authorized devices and comply with FDA requirements (or operate under FDA enforcement discretion) for any technology used in patient care delivery.

Overview

The ACCESS Model enables technology-supported care using various digital health tools. The FDA regulates many of these technologies to ensure safety and effectiveness. Understanding which of your tools are regulated—and how—is essential for ACCESS participation.

What the FDA Regulates

The FDA oversees:

Medical devices — Hardware used for diagnosis, treatment, or monitoring
Software as a Medical Device (SaMD) — Software intended for medical purposes
In Vitro Diagnostics (IVDs) — Tests and diagnostic tools
Combination products — Products combining drugs, devices, or biologics

Regulatory Pathways

Pathway	Description	Timeline
510(k) Clearance	Device is substantially equivalent to a predicate device	3-6 months
De Novo Classification	Novel low-to-moderate risk device	6-12 months
Premarket Approval (PMA)	High-risk devices requiring clinical data	1-3 years
Enforcement Discretion	FDA has chosen not to enforce for certain low-risk software	N/A

Digital Health Technologies in ACCESS

ACCESS care organizations may use various technology types, each with different FDA considerations:

Remote Patient Monitoring Devices

Wearable Devices

Devices that monitor vital signs, activity, sleep, or other physiological parameters. Many consumer wearables are FDA-cleared for specific health measurements.

Examples: Blood pressure monitors, continuous glucose monitors, pulse oximeters, ECG monitors

Connected Medical Devices

Traditional medical devices with wireless connectivity for data transmission to care teams.

Examples: Smart scales, connected blood pressure cuffs, home spirometers

Implantable Devices with Monitoring

Devices implanted in patients that transmit data remotely.

Examples: Cardiac monitors, implantable loop recorders

Software and Apps

Clinical Decision Support (CDS)

Software that provides recommendations to clinicians. Some CDS is regulated, while other types fall under enforcement discretion.

Digital Therapeutics (DTx)

Software-based interventions that treat or manage medical conditions. Most DTx products require FDA authorization.

Patient Engagement Apps

Apps for education, reminders, and engagement. Many fall under enforcement discretion if they don't make clinical claims.

Know Your Software Classification

Not all health software requires FDA clearance. Software that simply displays, stores, or transmits data without providing clinical recommendations may not be regulated. However, software that interprets data, provides diagnoses, or recommends treatments typically requires FDA authorization.

FDA Enforcement Discretion

The FDA has announced it will not enforce regulatory requirements for certain categories of low-risk digital health products. This allows innovation while maintaining safety for higher-risk technologies.

Categories Under Enforcement Discretion

The FDA generally exercises enforcement discretion for:

General wellness products — Products promoting healthy lifestyle without disease claims
Low-risk CDS — Certain clinical decision support that meets specific criteria
Electronic health records — EHR and practice management software
Patient communication tools — Secure messaging and appointment scheduling
Administrative software — Billing, scheduling, and workflow tools

When Enforcement Discretion Applies

For your software to fall under enforcement discretion, it typically must:

Not be intended to diagnose, cure, treat, or prevent disease
Present low risk to patients if it fails or malfunctions
Not replace clinical judgment for serious conditions
Be transparent about its intended use and limitations

Document Your Determination

Even if your technology falls under enforcement discretion, document your analysis of why it qualifies. This documentation may be requested during ACCESS application review.

Software as a Medical Device (SaMD)

Many ACCESS participants will use Software as a Medical Device. Understanding SaMD classification and requirements is critical.

What Qualifies as SaMD

Software is considered SaMD if it is:

Intended to be used for medical purposes
Capable of running on general-purpose computing platforms
Not part of a hardware medical device

SaMD Risk Classification

The FDA classifies SaMD based on the significance of the information provided and the healthcare situation:

Healthcare Situation	Non-Serious	Serious	Critical
Treat or Diagnose	Class II	Class II	Class III
Drive Clinical Management	Class I	Class II	Class III
Inform Clinical Management	Class I	Class I	Class II

Clinical Decision Support Criteria

The 21st Century Cures Act established criteria for CDS software that is NOT considered a device:

Intended for healthcare professionals
Intended to support clinical decision-making
Provides the basis for recommendations (transparency)
Allows the professional to independently review the basis

Does our AI algorithm require FDA clearance?▼

It depends on the algorithm's intended use and risk level. AI/ML that provides diagnosis or treatment recommendations for serious conditions typically requires FDA clearance. AI that provides lower-risk recommendations or falls under the CDS criteria may not. Consult with regulatory experts for your specific use case.

FDA TEMPO Pilot

The FDA's TEMPO (Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices) pilot program offers an alternative pathway for certain digital health devices in connection with ACCESS.

What is TEMPO?

TEMPO is a voluntary FDA pilot program that 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 when their device is offered to or by ACCESS participants.

TEMPO Benefits

Access to innovation — Enables use of promising devices before full FDA authorization
Real-world evidence — Generates data that may support future FDA marketing submissions
Patient safety — Maintained through risk mitigation plans discussed with FDA
Controlled context — Devices used within the structured ACCESS Model framework

Who Should Consider TEMPO?

Manufacturers may benefit from TEMPO if they:

Have digital health devices not yet FDA-authorized for an intended use to improve patient outcomes
Want to offer their devices in connection with the ACCESS Model
Are prepared to collect real-world data during participation
Plan to seek FDA marketing authorization using data collected during the pilot

FDA Digital Health Center of Excellence

Official FDA resource for digital health regulatory information

Compliance for ACCESS Participants

Before Applying

Ensure your technology portfolio is FDA-compliant:

Inventory Your Technology

List all devices, software, and digital tools you plan to use in ACCESS care delivery.

Classify Each Technology

Determine the FDA regulatory status of each:

FDA-cleared/approved (document clearance number)
Under enforcement discretion (document rationale)
Not a medical device (document analysis)

Address Gaps

If any technology requires FDA authorization you don't have:

Pursue appropriate FDA pathway
Consider alternative cleared technologies
Adjust your care model if needed

Document Everything

Maintain documentation of:

FDA clearance letters and numbers
Enforcement discretion analyses
Device labeling and intended use statements
Quality management procedures

During ACCESS Participation

Ongoing FDA compliance requirements:

Medical Device Reporting (MDR) — Report adverse events and malfunctions
Quality System Regulation (QSR) — Maintain quality management systems for devices
Labeling compliance — Use devices according to cleared indications
Post-market surveillance — Monitor device performance and safety

Off-Label Use

Using FDA-cleared devices for purposes outside their cleared indications (off-label use) may create compliance and liability issues. Ensure your care protocols align with device labeling.

Common ACCESS Technology Categories

By Clinical Track

Track	Common Technologies	Typical FDA Status
eCKM	BP monitors, weight scales, CGMs, coaching apps	Mix of cleared devices and enforcement discretion software
CKM	CGMs, BP monitors, kidney function tests, medication management	Mostly FDA-cleared devices
MSK	Motion sensors, pain tracking apps, exercise apps	Mix of cleared and enforcement discretion
BH	Digital therapeutics, mood tracking, therapy apps	DTx typically cleared; tracking apps may be enforcement discretion

Technology Examples by Regulatory Status

FDA-Cleared Devices:

Continuous glucose monitors (CGM)
Blood pressure monitors
Pulse oximeters
ECG monitors
Digital therapeutics for depression, anxiety, chronic pain

Typically Under Enforcement Discretion:

General wellness and fitness apps
Medication reminder apps
Patient education platforms
Symptom tracking journals
Lifestyle coaching apps (without clinical claims)

Resources

FDA Digital Health Resources

FDA Digital Health Center of Excellence

Central hub for FDA digital health guidance and resources

FDA AI/ML Software Guidance

FDA's approach to AI/ML-based Software as a Medical Device

Getting Help

For complex FDA questions, consider:

FDA Pre-Submission meetings — Formal meetings to discuss regulatory strategy
Regulatory consultants — Experts who specialize in FDA digital health
Industry associations — Groups like the Digital Therapeutics Alliance

Frequently Asked Questions

Do all digital health tools need FDA clearance?▼

No. Many digital health tools fall under FDA enforcement discretion or are not considered medical devices. The key factors are the intended use, the claims made, and the risk level. General wellness products, simple data display tools, and certain clinical decision support are often not regulated.

What if we use a third-party device or platform?▼

You can use third-party FDA-cleared devices in your ACCESS care delivery. Ensure the device is used according to its cleared indications and maintain documentation of the clearance. You remain responsible for appropriate use and integration into your care model.

How do we handle devices cleared for consumer use vs. clinical use?▼

Some devices have different clearances for consumer vs. clinical settings. Review the device's cleared indications carefully. Using a consumer device in a clinical context may require additional validation or may not be appropriate for ACCESS care.

What happens if FDA requirements change during our participation?▼

FDA regulations evolve over time. ACCESS participants must maintain ongoing compliance with current FDA requirements. Stay informed about regulatory changes and update your compliance documentation accordingly.

Can we develop our own technology for ACCESS?▼

Yes, but you must ensure your technology meets all applicable FDA requirements before using it with ACCESS patients. This may require going through an FDA clearance pathway, depending on your technology's intended use and risk level.

Is HIPAA compliance related to FDA compliance?▼

They are separate requirements. FDA regulates the safety and effectiveness of medical devices and software. HIPAA regulates the privacy and security of health information. ACCESS participants must comply with both, but they address different aspects of your operations.

Next Steps

Review All Eligibility Requirements

FDA compliance is one part of ACCESS eligibility

Start Your Application

Learn about the complete application process

Explore Clinical Tracks

Understand technology requirements for each track