Navigating digital therapeutics (DTx) FDA regulations and approval


Digital therapeutics (DTx) is revolutionizing how medical treatments are administered–making healthcare targeted, effective and accessible for patients and healthcare providers.

From virtual coaches to chronic condition management and care companions, digital therapeutic services provide a wide range of healthcare solutions that have already heralded major breakthroughs.

Whether you’re developing a DTx product for the EU, UK, US or other markets, keeping pace with complex regulatory regimes and changing regulations will significantly impact how quickly you can get your product to market. This post looks at some of the critical regulations around DTx products in the US market, including FDA medical device classification and regulatory approval processes.

Develop DTx products that meet the required regulations, gain FDA approval and go to market with these insights.

Understanding digital therapeutics (DTx)

DTx is an evidence-based, patient-centric technology which allows providers and patients to “treat, manage and prevent a range of behavioral, mental and physical diseases and disorders.” Combined with Artificial intelligence (AI), machine learning (ML) and natural language processing (NLP), DTx solutions are making it easier for patients to afford and access contactless care, manage disease and, in the long-term, yield favorable healthcare outcomes.

There are already various approved DTx products on the market. HabitNu, for example, is a preventive treatment for Type II diabetes recognized by the US Center for Disease Control (CDC) and already incorporated within the Centers for Medicare and Medicaid Services (CMS) reimbursement models.

Digital therapeutics regulations

Country-specific regulatory pathways and approval processes can prove challenging for DTx manufacturers. Since DTx is an emerging class of medicine, there is no universal roadmap for getting approval through existing regulatory bodies. Across all markets, DTx regulatory regimes differ depending on whether it’s classified as a medical device, software or service. Developing successful DTx digital health programs and getting them to market thus depends on several factors, including personalization, data security and privacy, and adept navigation of FDA/IMDR regulatory and approval processes.

Digital therapeutics FDA regulations

The FDA approved digital health technologies in 2017. But ongoing concerns related to DTx product classification, safety and use can complicate how approval is re-administered as apps change and improve over time.

Like therapeutic drugs or medical devices, DTx products undergo rigorous regulatory oversight. Most products are classified as Class I or II medical devices—meaning they are low-risk and generally require lower controls. They must be developed according to industry best practices, however. As such, DTx manufacturers should be aware of how device classifications may lengthen their DTx products’ regulatory and approvals process and time-to-market, especially if notified body approval is a long-term goal.

Medical device classification and pathways to regulatory approval

The following categories are an introductory guide to easing your DTx regulatory journey and time-to-market if you decide to pursue FDA approval. Ultimately, manufacturers must decide whether to categorize a DTx product as a medical device, pharmaceutical or a combination of the two.

  1. Class I: Service-based or SaMD (Software as a Medical Device) products do not require regulatory filing nor FDA regulatory adherence. The upside is a shorter time-to-market and quicker response to patients’ needs. However, the lack of clinical trial data could be a potential impediment to gaining physician buy-in.
  2. Class II: Devices that do not generally require a Pre-Market Approval (PMA) but need a 510(k) Pre-market notification or De Novo clearance.
    1. The 510(k) Pre-market Notification is used to evaluate a device similar to one already on the market.
    2. De Novo clearance: De Novo clearance is for novel devices with no similar market predicates
  3. Class III: DTx products in this category require pre-market approvals (PMA) due to the high risk to patients and the product’s use to ‘sustain or support human life.’ As the most stringent category for medical devices, Class III devices require large-scale clinical trials and take the longest time to market. But the payoff is worth it since there is a higher likelihood of physician-buy-in and large-scale adoption.

In 2017, the FDA launched the Pre-Cert Pilot Program. Though limited to SaMD manufacturers, it’s a small step for tailored regulatory oversight, streamlining pre-market review and establishing a foundation for future regulatory approval models for SaMD and digital therapeutics technologies.

What’s next?

For device manufacturers, the dizzying list of requirements can be overwhelming. Consulting the FDA’s online database of medical devices to understand what class your device belongs to and required documentation and validation procedures are crucial first steps.

If you’re looking for further guidance, Star’s HealthTech consulting services can help. Star technology consulting helps companies navigate complexity to craft MedTech and digital healthcare products that improve people’s lives worldwide. The multinational team of regulatory and product strategists, designers and engineers will support you at every stage of your medical device product journey.