Concept renderFDA lists software that tracks medications and sends user-configured reminders among functions where it intends to use enforcement discretion, and says such functions may still meet the device definition. This guide sorts feature wording into likely buckets as our reading of the sources as of October 31, 2026, with a spec checklist.
You are adding reminders to a companion device for older adults, and you want to ship them without making a medical device claim by accident. This is an engineering summary for general wellness products. It is not a guide to medical devices, and it is not legal advice. It covers adults and older adults only.
The table below is our reading of the quoted sources. It is not an FDA ruling and it has not been reviewed by FDA. Have regulatory counsel review it against your real product before you rely on it.
What does FDA say about medication reminders?
The FDA list of software functions for which it will exercise enforcement discretion includes "software functions that keep track of medications and provide user-configured reminders for improved medication adherence" (FDA list, as of October 31, 2026).
The same page explains what that means. "Even though these software functions may meet the definition of medical device, the FDA intends to exercise enforcement discretion for these software functions, because they pose lower risk to the public." Enforcement discretion does not take the function out of the device definition. FDA says it may meet the definition and chooses not to enforce. Your spec and your copy should never say the feature is excluded from the definition.
Two phrases carry the weight in the list entry: "user-configured" and "reminders." Our reading is that the closer your feature stays to those two words, the closer it stays to the entry.
What do the statute and the guidance pages add?
- Healthy-lifestyle exclusion. Section 520(o)(1)(B) of the FD&C Act (21 USC 360j(o)) covers software "for maintaining or encouraging a healthy lifestyle ... unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition" (21 USC 360j, as of October 31, 2026). Reminder wording tied to a condition or treatment falls outside it.
- Clinical decision support exclusion. Section 520(o)(1)(E) is aimed at health care professionals and requires that they can independently review the basis for recommendations. It does not cover consumer-facing features. We read the statute text only. We did not open the clinical decision support guidance document.
- Policy for Device Software Functions. The FDA guidance page shows "Content current as of: 09/28/2022." It covers software that meets the device definition and also gives examples of software functions that do not (FDA guidance page, as of October 31, 2026).
- General wellness policy. The FDA page, current as of 01/06/2026, describes the policy as covering "low risk products that promote a healthy lifestyle" (FDA general wellness page, as of October 31, 2026).
We read the lines quoted here. We did not read the full text of the enforcement-discretion framing beyond them.
Which feature wording lands where?
Each row is a feature wording and the bucket we think it points to, based only on the quoted text. The buckets are: (a) user-configured reminder or log, on the FDA enforcement-discretion list; (b) general-wellness framing; (c) wording that adds disease, diagnosis or dosing advice and moves toward device status.
| Feature wording | What the feature does | Our reading of the likely bucket | Source |
|---|---|---|---|
| "Reminds me at 8am to take my pills" | The user sets the time and the content. The device repeats it. | Matches the FDA list entry for user-configured reminders. The list says these functions may still meet the device definition, and FDA chooses not to enforce. | FDA enforcement-discretion list, as of October 31, 2026 |
| "Keeps a log of what I marked as taken" | The user taps to record. The device stores the entry and shows it back. | Fits the "keep track of medications" part of the same list entry. Our reading: it stays here while the device only shows what the user entered. | FDA enforcement-discretion list, as of October 31, 2026 |
| "Reminds me to drink water and stand up" | No disease or treatment is named. | General wellness framing. The statute excludes software for a healthy lifestyle only if it is unrelated to a disease or condition. | 21 USC 360j, as of October 31, 2026 |
| "Reminds you to take your blood pressure pills" | Ties the reminder to a named condition and a treatment. | The wording relates to treatment of a condition, so the healthy-lifestyle exclusion no longer fits. The enforcement-discretion entry may still cover a plain reminder. Ask counsel which one you rely on. | 21 USC 360j, as of October 31, 2026 |
| "Tells me if I missed a dose that matters for my condition" | The device judges the importance of a missed dose for a condition. | Adds disease context and a judgment. Our reading: this moves toward device status and goes beyond the quoted list entry. | FDA enforcement-discretion list, as of October 31, 2026 |
| "Suggests what to do after a missed dose" | The device gives dosing advice. | Our reading: dosing advice is outside everything quoted here. Treat it as a device function until counsel says otherwise. | FDA enforcement-discretion list, as of October 31, 2026 |
| "Shows your clinician a recommendation with the reasoning" | Aimed at a health care professional who can review the basis. | The clinical decision support exclusion in 520(o)(1)(E) is aimed at health care professionals. A consumer-facing feature does not use it. | 21 USC 360j, as of October 31, 2026 |
Rows one and two map to bucket (a). Row three maps to bucket (b). Row four sits between (a) and (c) and needs counsel. Rows five and six map to bucket (c). Row seven points to the clinical decision support exclusion, which is aimed at health care professionals. It sits outside buckets (a) to (c). Our reading is that a consumer-facing version cannot rely on it, and whether a clinician-facing version qualifies is a question for counsel. This table is our reading of the sources. It is not an FDA ruling.
What is the quoted text, line by line?
So you can check our reading, here are the lines we relied on.
| Source | Quoted line |
|---|---|
| FDA enforcement-discretion list, accessed October 31, 2026 | Software functions that keep track of medications and provide user-configured reminders for improved medication adherence; |
| FDA enforcement-discretion list, accessed October 31, 2026 | Even though these software functions may meet the definition of medical device, the FDA intends to exercise enforcement discretion for these software functions, because they pose lower risk to the public. |
| 21 USC 360j (Cornell LII), accessed October 31, 2026 | for maintaining or encouraging a healthy lifestyle ... unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition |
| 21 USC 360j (Cornell LII), accessed October 31, 2026 | enabling such health care professional to independently review the basis for such recommendations |
| FDA policy for device software functions, accessed October 31, 2026 | Content current as of: 09/28/2022 |
| FDA general wellness policy, accessed October 31, 2026 | low risk products that promote a healthy lifestyle |
What should the spec and the UI copy checklist say?
Use this as a go or no-go list for the spec. A no on any line is a reason to stop and ask counsel.
- The user sets the reminder time and the reminder text. The firmware does not pick either one.
- The log shows what the user entered. Nothing in the log is scored, interpreted or compared to a target dose.
- Reminder copy names no disease, condition or treatment unless counsel has approved that wording.
- No screen, voice line or notification says a missed reminder is dangerous, urgent for a condition, or affects health outcomes.
- No feature suggests a dose, a changed dose or what to do after a missed dose.
- Store listings, packaging and marketing use the same wording as the in-app copy. A claim made anywhere is a claim.
- The spec lists every place reminder text can appear: device display, voice output, companion app, notifications, emails and store pages.
- Regulatory counsel has checked the table in this article against your actual screens and wording.
Words to avoid in app copy, store listings and marketing
These words push a reminder toward treatment, diagnosis or dosing. The list comes from the statute wording quoted above and from our reading of the sources. Counsel may add to it.
| Words | Why they are risky |
|---|---|
| treat, treatment, therapy | These words tie the product to treatment of a condition. |
| diagnose, detect, screen for | These words describe diagnosis. |
| prevent, cure, manage a disease | The statute text quoted above names prevention, cure and mitigation. |
| your condition, your prescription, your medication regimen | Ties the reminder to a named health problem or treatment. |
| clinically proven, medical grade, doctor recommended | Implies a medical purpose and a level of evidence this article does not source. |
| dosage advice, correct dose, safe to take | Dosing advice sits outside the sources quoted here. |
What are the common traps?
These follow from the quoted text. They are engineering reasoning. None of them reports an incident at any company.
- Copy that drifts from the spec. The enforcement-discretion entry covers "user-configured reminders." If a later release lets the device choose reminder times or add condition-specific messages, the feature no longer matches the quoted wording. This is engineering reasoning from the quoted text. It does not describe an event at any company.
- Reading enforcement discretion as an exclusion. FDA says these functions may meet the device definition and it chooses not to enforce. A team that writes "this is not a medical device" in a spec or listing has restated the list entry incorrectly.
- A wellness label on disease wording. The healthy-lifestyle exclusion applies only when the software is unrelated to a disease or condition. A reminder that names a condition does not become wellness because the product category is wellness.
- Using the clinical decision support exclusion for a consumer feature. The exclusion in 520(o)(1)(E) is aimed at health care professionals who can independently review the basis for recommendations. An elder-facing screen does not fit that description.
- Relying on guidance pages without their dates. The FDA policy page shows content current as of 09/28/2022, and the general wellness page shows content current as of 01/06/2026. Pages can be updated again, so re-read them before launch.
What should you test on your own device?
No source here describes how a real reminder interface behaves, including snooze or escalation to a caregiver. We have not built or tested one for this article, so none of it is described as verified. Test on your own prototype. The pass line is yours to set by product requirement, and you should record the basis for it.
| What to test | How to instrument or collect it | Raw data to record |
|---|---|---|
| Every string a user can see or hear | Export all reminder-related text from firmware, voice prompts, the companion app, notifications and the store listing into one file. Search it for the words in the avoid list. | The exported file, the list of words searched, each hit and its location, and the reviewer who cleared it. |
| User-configured behavior | Walk through setup on a prototype. Record who chooses the time, the text and the repeat pattern at each step. Confirm the device never changes them on its own. | Screen recordings of setup, a table of each setting and who sets it, and any step where the firmware proposes a value. |
| Log content | Enter, edit and delete log entries on a prototype. Check whether any screen derives a score, a streak message or a judgment from the entries. | Screenshots of every log view, the logic that builds each message, and a note on whether any message comes from the device and not the user. |
| Missed-reminder handling | Leave a reminder unacknowledged on a prototype and record exactly what the device shows, says and sends. Do not describe escalation to a caregiver as verified until you have run it yourself. | Timestamped device logs, display captures, audio captures of any spoken line and the exact notification text. |
| Wording consistency across surfaces | Place the in-app copy, the store listing text, the packaging text and the website claim next to each other and compare them line by line. | A side-by-side table with the source file of each string and any mismatch. |
What should you ask before you decide?
- Does every reminder on the device come from a setting the user chose, and where in the spec is that written?
- Which exact FDA page and date does our regulatory memo cite, and when do we re-read it before launch?
- Does any string name a disease, a condition or a treatment, and did counsel approve it?
- Does the log do anything other than show back what the user entered?
- If a caregiver is involved, what does the caregiver see, and has counsel reviewed that flow?
- Which team handles data from the log, and what has counsel told us about it? This article does not cover it.
- Who owns store listing and marketing copy, and who checks it against the in-app copy?
- What would we have to change in the spec if counsel says a row in the table sits in a different bucket?
What this article leaves out
The sources we opened say nothing on HIPAA or on how to store, collect consent for or share adherence data, including sharing with a caregiver. We do not cover those topics here. Until a primary source from HHS or FTC has been read, treat them as questions for counsel. The FDA guidance pages carry update dates, so re-read them before launch.
Questions about medication reminders and the FDA line
Does FDA say a medication reminder is not a medical device?
No. The FDA enforcement-discretion list says that even though these software functions may meet the definition of a medical device, FDA intends to exercise enforcement discretion because they pose lower risk. The function is listed as "keep track of medications and provide user-configured reminders for improved medication adherence" (FDA list, as of October 31, 2026).
Can I call the feature "general wellness"?
Only if the wording is unrelated to a disease or condition. The statute text in 520(o)(1)(B) excludes software for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition (21 USC 360j, as of October 31, 2026). A reminder that names a condition falls outside that exclusion.
Does the clinical decision support exclusion help a consumer product?
Our reading of the statute text is that it does not. The exclusion in 520(o)(1)(E) is aimed at health care professionals and requires that they can independently review the basis for recommendations. We read the statute text only. We did not read the clinical decision support guidance document itself.
What about adherence data, caregiver sharing and HIPAA?
This article does not cover them. The sources we opened say nothing on those topics, and we have not yet read a primary source from HHS or FTC. Take those questions to regulatory counsel.
Is this table legal advice?
No. It is an engineering team's reading of the quoted sources and does not constitute legal advice. It is also not an FDA ruling and does not show FDA agrees with any specific product. Have regulatory counsel review your actual screens and wording.
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Sources
All pages accessed October 31, 2026. Guidance pages are updated over time, so re-read them before you decide. This is an engineering summary and does not constitute legal advice.
- FDA, Examples of software functions for which FDA will exercise enforcement discretion: https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-which-fda-will-exercise-enforcement-discretion (accessed 2026-10-31)
- Cornell Legal Information Institute, 21 USC 360j: https://www.law.cornell.edu/uscode/text/21/360j (accessed 2026-10-31)
- FDA, Policy for Device Software Functions and Mobile Medical Applications: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications (accessed 2026-10-31)
- FDA, General Wellness: Policy for Low Risk Devices: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices (accessed 2026-10-31)
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