Is Your AI-enabled Smartphone App a Medical Device?

Promise and Regulation of AI-Enabled Smartphone Apps

Recent research has shown promising potential for smartphone selfies to aid in artificial intelligence (AI)-enabled screening and diagnosis of various medical conditions, such as neonatal jaundice, coronary artery disease, skin cancer, and eye disease. Capitalizing on this potential, a growing number of public-facing apps using AI technology have emerged, allowing consumers to upload smartphone selfies for image analysis. These apps aim to provide health-related outputs, ranging from vital signs, such as heart rate and blood pressure, to screening for specific disease conditions. 

However, it is crucial  to understand that many of these apps fall under the regulatory oversight of the US Food and Drug Administration (FDA). Manufacturers must ensure compliance with FDA regulations, including pre-market clearance for products classified as Software as a Medical Device (SaMD). The FDA pre-market regulatory framework ensures that medical devices, including SaMD, meet safety and effectiveness standards and data requirements before they reach consumers.  Consumers, in return, need to be aware of the regulatory landscape and prioritize FDA-cleared apps when seeking reliable health information through AI-enabled technology.

Understanding Regulations: Definitions of Medical Device and SaMD

However, there is often confusion regarding the classification of AI-enabled apps, particularly whether they qualify as SaMD. Understanding the definitions of Medical Devices and SaMD will help consumers make informed decisions about using these apps that process their personal health data, prioritizing those with FDA clearance for safety and effectiveness. To help determine whether an AI-enabled app qualifies as SaMD, let’s examine the relevant definitions.

Definition of Medical Device

The definition of a medical device is found in Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act): “A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or …”

Per the International Medical Device Regulators Forum (IMDRF) document IMDRF/SaMD WG/N10FINAL:2013 SaMD: Key Definitions, it is also defined as: “Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: 

• diagnosis, prevention, monitoring, treatment, or alleviation of disease, 

• diagnosis, monitoring, treatment, alleviation of, or compensation for an injury, 

• investigation, replacement, modification, or support of the anatomy, or a physiological process …”

Definition of Software as a Medical Device (SaMD)

For the definition of SaMD, the US FDA refers to the document IMDRF/SaMD WG/N10FINAL:2013 SaMD: Key Definitions in which: “SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. … SaMD may also: 

• provide means and suggestions for mitigation of a disease;

• provide information for determining compatibility, detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illness, or congenital deformities;

• is an aid to diagnosis, screening, monitoring, determination of predisposition; prognosis, prediction, determination of physiological status.”

Any AI-enabled apps providing information regarding a medical condition in the ways described above are SaMD. Therefore, manufacturers of such apps would need to meet the existing regulatory requirements, including establishment registration and regulatory clearance with the US FDA, to market their products for sale in the US. Furthermore, manufacturers claiming that their AI-enabled apps are not SaMD should consider provisions on the misbranding in Section 502 of the FD&C Act, which may apply to their apps, including but not limited to:

• A device is deemed to be misbranded if its labeling is false and misleading.

• The device commercially distributed without FDA concurrence on a 510(k) submission.

• The device is subject to a performance standard and it does not bear the labeling prescribed in that standard.”

It is important to note that misbranding is prohibited under Section 301 of the FD&C Act.

Non-Medical Device General Wellness Products

AI-enabled apps and software products are considered non-medical devices if they fall into the categories of low-risk, general wellness products as defined per the FDA guidance as follows: “A general wellness product has:

1. an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or 

2. an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.” 

The first category doesn’t include any intended use cases that make a reference to diseases or medical conditions and only includes general wellness claims, such as weight management, physical fitness, and sleep management. The second category has two subcategories of claims: “

• intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and 

• intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.”

Examples of chronic diseases in the second category include heart disease, high blood pressure, and type 2 diabetes. Please see the FDA guidance for the full list of general wellness product claims and examples.

Conclusion

When developing public-facing, AI-enabled smartphone apps that address health conditions, manufacturers have a responsibility to ensure that their products are safe and effective. To align products with regulations, consulting with a regulatory expert and proactively seeking feedback from the FDA via the Q-submission program is essential. This program helps manufacturers get early input on product classification and potential regulatory pathways.

Consumers should also actively safeguard their health by understanding the difference between SaMD, which requires FDA clearance, and general wellness products. When managing specific health conditions, prioritizing FDA-cleared SaMD apps is crucial. While FDA clearance indicates a certain level of safety and potential effectiveness, it's always best to discuss any health apps with your physician for the most personalized guidance.

This article was originally published on Subok Park's LinkedIn Page.