Medical Devices and Digital Therapeutics: Many Ways to Get to Market

Most people know that for a prescription drug to be on the market, it must receive approval from the United States Food and Drug Administration (FDA). Did you know that many medical devices and Digital Therapeutics (DTx) are also approved and regulated by the FDA?

What are medical devices and how are they different from DTx?

Medical devices are defined by the FDA as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.” Some examples of medical devices include blood glucose monitors, insulin pumps, and heart monitors.

The Digital Therapeutics Alliance defines digital therapeutics as “a subset of digital health, evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.” To read more on digital therapeutics, click here for a previous PHSL blog post on the topic. While medical devices have been around for quite some time, digital therapeutics are a more recent development in the medical world. Some examples of digital therapeutics include reSET (a 90-day program for adults with substance use disorders), Somryst (an application for adults with depression and insomnia), and EndeavorRx (a video game for children with ADHD).

With hundreds of thousands of smart phone applications offering health-related functions, it is important to note that most of these digital health tools do not require FDA approval, since they are deemed relatively low-risk. As the name implies, Prescription Digital Therapeutics (PDTs), on the other hand, require a prescription and may come to the market in one of several ways.

The FDA segments devices into three classes, with “computerized behavioral therapy devices” (i.e., digital therapeutics) being listed as a Class II device. FDA guidance on the classification of medical devices is as follows:

• Class I- low risk. Class I devices pose almost no risk to patient safety and require the least regulatory control.
• Class II- moderate risk. Class II devices require regular assessment or premarket notification to prove safety and effectiveness.
• Class III- high risk. Class III devices are vital to health maintenance and even survival of patients. They are the most tightly regulated class of devices and require premarket approval.

For DTx products seeking to come to market, several pathways may be followed.  If a device manufacturer can show that their product is substantially equivalent to an existing product and demonstrates benefit, the manufacturer may be able to submit for 510(k) clearance, also known as premarket notification, or PMN.  For newer low to moderate risk devices where no existing device exists for comparison and a PMN is not an option, manufacturers may seek to be approved as de novo.  For these products, manufacturers will need to provide clinical data to show that the digital therapeutic is both safe and effective.  For newer devices that fall into the high risk, class III category, manufacturers will need to submit for premarket approval, or PMA.  For these products, manufacturers will need to provide clinical data showing that the product is both safe and effective for its intended use.

Before sending an application to the FDA, sponsors must also pay medical device establishment user fees and provide various other documentation, including eCopy (electronic copies of FDA device submissions), eSTAR (electronic submission template and resources), and an outline of small business determination program highlighting price reduction in user fees. When preparing applications, sponsors should consider important aspects of regulation including design controls, nonclinical testing, consensus standards, clinical evidence, and labeling requirements.

What happens after the FDA receives the application?

The FDA will perform a series of reviews. An administrative review will be conducted to ensure that the submission is sufficiently complete to FDA standards. After the administrative review, device submissions will then undergo an interactive review. During the interactive review, the FDA will contact applicants and efficiently move through the review. Sponsors are also able to track their submissions through an online portal provided by the FDA.

After the FDA reviews the device and decides that it can be brought to market, a series of steps must be taken before the device is available to patients.  Note that all of the step components may not be applicable for DTx products, as a physical product is not created.

1. Sponsors must register their organization, their location, and list the medical device(s) they market with the FDA.
2. Sponsors must practice Good Manufacturing Practices when producing the device
3. Sponsors must follow labeling requirements and follow regulations established by the FDA.
4. Sponsors must ensure that their devices are not misbranded or adulterated.

Is there any way to expedite this process?

Yes, the FDA established a new program in 2017 called the Breakthrough Devices Program which expedites the process, allows sponsors to receive feedback more quickly, design flexible clinical trials, and ultimately get the device to market quicker. As of 2021, 617 medical devices qualified for the program. For example, EndeavorRX, the video game for children with ADHD, took this route. By expediting the approval process, digital therapeutics are made available faster to help more people.

Similarly, the FDA developed the Safer Technologies Program (STeP) to expedite the approval of devices for less serious conditions.

Finally, the FDA implemented a precertification pilot program consisting of nine volunteer companies with the goal of developing a new regulatory framework focusing on medical devices and technology. While the pilot program is still in progress, it was designed to be adaptive to fix medical software glitches as quickly as possible. Interestingly, the FDA regulates the companies rather than the devices themselves under this model.

Where do digital therapeutics fit in?

As of now, digital therapeutics follow the same pathways as other devices in the market.  Do you think that a new regulatory framework designed specifically for digital therapeutics will come into effect as a subset of medical devices? How do you think this will impact the market?

Posted August 2023