The Rise and Importance of Digital Health

The FDA has established classifications for approximately 1,700 different generic types of devices, where they are regulated to different degrees based on the level of control necessary to assure the safety and effectiveness of the device¹. With the various kinds of digital health products, it can be confusing to know what classification you may be working with, and if that digital product will be regulated by the FDA or not. Developers & stakeholders need to understand if their product will be subject to the FDA’s regulatory process, or they run the risk of not getting their product to market, all while spending both time and money in development, testing, and validation.

What’s the Risk?

The FDA utilizes a risk-based approach to regulating digital health products that could be considered a medical device. This means they assess the product by “weighing any probable benefit to health from the use of the device against any probably risk of injury or illness from such use”².

So, what is the risk if someone uses this product incorrectly, or if the product malfunctions? Is there a chance that the user could harm themselves or others? Are the benefits of using the device greater than the risks?

With these questions in mind, the FDA may classify your product in one of the following three categories:

General wellness products

Digital products or treatments that meet the definition of Software as Medical Device (SaMD)

Digital products or treatments that meet the definition of SaMD, but pose a low risk to the user, and qualify for enforcement discretion

General Wellness Products

The FDA may not regulate your digital product if there is a low risk to the safety of the user and other persons. More specifically, the FDA has articulated that any software “intended for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition is not considered a medical device”³. These kinds of products are called general wellness products, and they must meet two factors:

They must be intended for only general wellness use

They must present a low risk to the safety of users and other persons (General Wellness: Policy for Low Risk Devices Guidance for Industry and Food & Drug Administration)⁴.

A specific example of this product may look like a software function that plays music to ‘soothe and relax’ an individual and to ‘manage stress’. This product would not be classified as a medical device, since the software function has claims that only relate to relaxation or stress management, rather than any disease or medical condition.

Digital Products that meet the definition of SaMD

If your product is a digital tool that intends to diagnose, treat, or manage a medical condition, then it may be classified as Software as a Medical Device (SaMD) and will be subject to FDA oversight and regulation. The International Medical Device Regulators Forum defines SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”⁵. In the United States, SaMD products typically follow a de novo or 510(k) regulatory pathway.

One common example of a digital product that falls under SaMD would be medication management software. This could be an app that assists healthcare professionals to help them manage the scheduling, stocking and delivery of medications to patients. This falls under the SaMD category because it is intended for a medical purpose, and since it’s an app, there is not any hardware involved.

Digital products that meet the definition of SaMD, but qualify for enforcement discretion

Lastly, the third category: Digital tools that meet the definition of a SaMD, but since they post a low risk to the user, they qualify for enforcement discretion and can go to market without active FDA oversight.

These products meet the SaMD definition since they are intended for medical purposes. But since these products pose a lower risk to the user, the FDA will exercise enforcement discretion. In this context, enforcement discretion means that “the FDA does not intend to enforce applicable requirements under the FD&C Act at this time”⁶.

An example of this could be software that uses global positioning system (GPS) location information to alert asthmatics of environmental conditions that may cause asthma symptoms. This could look like a mobile app that sends a notification to the user when they are in an area with poor air quality. This differs from the general wellness products since this product is intended specifically for a medical purpose, but since it poses a low risk to the user, the FDA will exercise enforcement discretion rather than the full regulatory review process (such as a De Novo or 510(k)).

The Roadmap to Approval

There can be perceived gray areas when determining the FDA classification for a product.

So, how can stakeholders and developers receive approval, and what does the process and steps to approval look like?

At Innovenn, we began working in the digital health space in 2014 and have grown as experts in the development of digital health solutions which can also be characterized as Software as A Medical Device (SaMD). Our team can assist with the design, development, validation, and logistical planning for the launch of digital health products and other SaMD products.

Choosing Innovenn for your digital health product needs provides access to a depth of experience in design controls, software development, Human Factors Engineering, user experience, regulatory, privacy, and security who can support the development of health changing solutions. With an understanding of the importance of getting products to market as efficiently as possible, Innovenn always keeps patient needs in the center of development decisions.

Why Choose Innovenn for your Digital Health projects?

It’s important to examine the regulatory requirements before spending too much time, resources, and money going down a path that may not lead to FDA approval or your corporate goals. To learn more and speak to our Subject Matter Experts, please contact us.

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