Start with the claim, not the code
Under the FD&C Act, software is regulated by its intended use, which shows up in your labeling, marketing, app-store copy and in-app text. The same algorithm on the same sensor can be a wellness product or a medical device depending on what you say it does. FDA's own starting points are How to Determine if Your Product is a Medical Device and the interactive Digital Health Policy Navigator. This page walks through the same logic in five questions.
This is an orientation, not a regulatory determination or legal advice. For a borderline product, consider a 513(g) request or a Pre-Submission with FDA.
The five-question decision flow
- Does any claim involve diagnosing, curing, mitigating, treating or preventing a disease or condition? If no, and the product only supports general health (fitness, sleep, stress, weight), it may fall under FDA's General Wellness policy, provided it is also low risk. If yes, continue.
- Is it low risk, meaning not invasive, not implanted, and not using a technology that poses risk if it fails, such as lasers or radiation? Failing this takes the product out of the wellness policy even with modest claims.
- Is the software a device software function or something FDA has excluded? Section 520(o) of the FD&C Act excludes some functions, including administrative support, certain EHR functions, and some clinical decision support. Functions that analyze physiological signals or medical images are generally not excluded.
- If it supports clinical decisions, does it meet all four non-device CDS criteria? Under FDA's Clinical Decision Support Software guidance (updated January 2026), non-device CDS must not process medical images or signals, must display or analyze medical information, must support a healthcare professional by giving recommendations or options rather than a single specific directive, and must let that professional independently review the basis for the recommendation. Patient-facing decision software doesn't qualify under these criteria.
- If it is a device, does FDA say it intends to exercise enforcement discretion for this function? See the section below. If not, plan for a pathway (510(k), De Novo or PMA) and design controls; see SaMD consulting.
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Same sensor, two different products
FDA's General Wellness guidance (updated January 6, 2026) says non-invasive sensing that estimates values such as blood pressure, SpO2, glucose or heart rate variability can stay within the wellness policy, but only if the product doesn't claim to diagnose or monitor disease, doesn't present clinical-grade values without validation, and doesn't prompt clinical action. Here is how a wrist-worn optical sensor reads on each side of that line:
| Topic | Likely general wellness | Likely medical device |
|---|---|---|
| Purpose | "Track your heart rate variability as part of managing everyday stress" | "Detects atrial fibrillation" or "monitors patients with heart failure" |
| Disease references | None, or the guidance's healthy-lifestyle form, where a healthy lifestyle may help reduce the risk or impact of a well-understood chronic condition | Names a disease, a diagnostic threshold, or a patient population being monitored |
| Alerts | A general note that a healthcare professional may be able to help, without naming a disease | "Your reading indicates hypertension; contact your doctor" or alarms tied to clinical thresholds |
| Values shown | Trends and estimates framed for wellness, not presented as clinical-grade | Clinical-grade or equivalence claims ("as accurate as a cuff") or values intended for clinical decisions |
| Guidance to the user | Lifestyle suggestions such as sleep, activity or breathing exercises | Treatment guidance, such as medication or dosing changes |
| Substitution | Not intended to replace an FDA-authorized device | Marketed as a substitute for an authorized device |
Source: FDA, General Wellness: Policy for Low Risk Devices. Examples are paraphrased for illustration; read the guidance's own examples for your product category.
Enforcement discretion: device, but FDA doesn't intend to enforce
Some software meets the device definition, but FDA has said it intends to exercise enforcement discretion, meaning it doesn't plan to enforce requirements, for low-risk functions. FDA's Policy for Device Software Functions and Mobile Medical Applications (September 2022) gives examples, including software that:
- helps patients with diagnosed conditions self-manage their disease without giving specific treatment suggestions;
- gives simple tools to organize and track health information;
- gives easy access to information about a patient's condition or treatment;
- helps patients document, show or communicate potential medical conditions to their providers;
- performs simple calculations routinely used in clinical practice.
Enforcement discretion is a policy, not an exemption: it can change, and it doesn't cover functions FDA calls out as its focus. Check the current guidance list on FDA's digital health guidances page before relying on it. If your product uses AI, also see healthcare AI consulting.
Frequently asked questions
Is a wellness app that measures heart rate a medical device?
Not necessarily. Under FDA's General Wellness guidance (updated January 2026), a low-risk, non-invasive product making only general wellness claims is outside FDA's device focus, even if it estimates values like heart rate variability. It moves toward being a device when it names a disease, uses clinical thresholds or alerts, gives treatment guidance, or claims clinical-grade accuracy.
What is the difference between a device and enforcement discretion?
Enforcement discretion means the software may meet the definition of a device, but FDA has said it doesn't intend to enforce device requirements for that low-risk function. Examples are in FDA's Policy for Device Software Functions and Mobile Medical Applications. It is a policy that can change, not a statutory exemption.
Can clinical decision support software avoid FDA regulation?
Some can. Software is excluded from the device definition only if it meets all four statutory criteria described in FDA's CDS guidance: it doesn't process medical images or signals, it displays or analyzes medical information, it supports a healthcare professional's decision, and the professional can independently review the basis for the recommendation.
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