Regulatory Status of Digital Health Products

The core idea: intended purpose decides

Whether software is regulated as a medical device usually turns on what it is intended to do, not on whether it is an app. A tool that claims to diagnose, treat or manage a condition is treated differently from one that promotes general wellness. Rules differ by country, and this page names the jurisdiction, regulator and source for each statement. It is information only, not legal or medical advice, and rules change. Regulators outside the US, EU, UK and Germany (for example Health Canada or Australia's TGA) were not read for this page and are not verified here.

Labels used here: authorized means a regulator made a decision about a named product and use; marketing claim means a company's statement with no regulator decision behind it.

United States (FDA)

• Software can be a device. The FDA applies a risk-based approach to device software functions and says its oversight focuses on software that poses greater risk if it does not work as intended. [1]
• Enforcement discretion for some low-risk tools. For many functions that meet the device definition but pose minimal risk, the FDA says it will not expect premarket review or registration. Examples include functions that help patients self-manage a condition without providing specific treatment suggestions. [1]
• General wellness. The 21st Century Cures Act removed from the device definition software intended for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition. [2]
• Decision support for clinicians. FDA guidance (January 2026) explains which clinical decision support functions are excluded from the device definition and says existing digital health policies still apply to device software functions, including those intended for patients or caregivers. [3] The FDA's FAQ states that software meant to support time-critical decision making does not meet the definition of non-device decision support. [4]
• AI-enabled devices. The FDA keeps a public list of AI-enabled devices authorized for US marketing, whose entries have met applicable premarket requirements. The list is not comprehensive. [5] The FDA also said it will explore ways to identify devices that include large language model functionality. [5]
• Generative AI for mental health. On November 6, 2025, the FDA's Digital Health Advisory Committee discussed benefits, risks and mitigations for generative AI-enabled digital mental health medical devices, including premarket evidence and postmarket monitoring. [6] We did not verify whether any such device is authorized.

A named example, and what it shows

For EndeavorRx, the FDA database lists a De Novo request from Akili Interactive Labs, classified as "digital therapeutic software for attention deficit hyperactivity disorder" (regulation 882.5803), decision granted June 15, 2020. [7] That is a decision about one product and its stated use. It is not evidence that other apps for ADHD, or other conditions, are authorized, and the database page does not show how well it works. For the difference between wellness apps and prescription digital therapeutics, see digital therapeutics vs wellness apps.

European Union

• Medical device software. Commission-endorsed guidance (MDCG 2019-11, revision 1, June 2025) says software is qualified and classified by its intended purpose, regardless of where it runs, and that it applies to apps on phones or in the cloud. [8] It defines intended purpose by the manufacturer's label, instructions and promotional or sales materials. [8] The document states that it is not legally binding. [8]
• AI Act. The European Commission says the AI Act entered into force on 1 August 2024 and became applicable on 2 August 2026, with exceptions. Rules for high-risk AI in regulated products have an extended transition to 2 August 2028. [9] The page does not say how this applies to a specific health product, so check the legal text for any product.

United Kingdom (MHRA)

The MHRA says that in the UK many software products, including AI, are regulated as medical devices. [10] Its February 2025 guidance on digital mental health technologies explains how a product's intended purpose, qualification as a device and risk class are determined. [11] For the public, the MHRA says some digital mental health tools are classed as medical devices, for example those claiming to diagnose, treat or manage a condition, and must display a CE or UKCA mark. It also says not all such tools are regulated as devices, and that wellbeing or lifestyle products may not have been through the same checks. [12]

Germany (BfArM)

Germany's BfArM keeps a directory of reimbursable digital health applications (DiGA) and says the directory shows which have successfully completed its assessment procedure. [13] That is a national reimbursement route, not a worldwide approval.

What a regulatory status does and does not show

• Authorization is for a named product and use. See approved product vs approved indication.
• "FDA registered" is not "FDA approved." See the claim check on FDA registration.
• Authorization is not proof of benefit for every claim a company makes. Look for product-specific trials: product-specific trials for digital health products.
• No status can tell you a tool is right for you. Talk with a clinician; do not stop or change treatment because of an app.

Limits

Regulatory pages change often; we cite the date each was read. Whether a given app falls inside a regulated category depends on its exact claims, which this page cannot judge.