FDA Pre-Submission Meetings Enabling De Novo Authorization of Home-Based Virtual Reality Therapy for Chronic Lower Back Pain

1. Background and regulatory context

A developer of scientifically proven prescription virtual reality-based therapeutics for chronic pain management sought to create an optimized product that addresses patient, clinician, payer, and public health needs. The product is a prescription-only, cognitive behavioral therapy-based, home-delivered virtual reality therapy designed to reduce pain and the impact of pain on function through non-pharmacological mechanisms. Chronic pain affects more than 100 million Americans and incurs an estimated annual cost of 635 billion dollars. Traditional treatment with opioids carries risks of misuse and addiction, making safe and effective non-pharmacologic alternatives essential.

2. The opportunity and market need

Chronic pain represents a significant public health challenge with substantial economic burden. Treating it with opioids can lead to possible misuse and addiction. Virtual reality treatment offers a safe and effective non-pharmacologic option to reduce pain and pain intensity without the risks associated with opioids and other interventions. The therapy aims to deliver cognitive behavioral therapy that reduces the burden of chronic pain and increases function through an emotional, cognitive, and behavioral approach. Public and private payers in the United States do not cover prescription cognitive behavioral therapy products without FDA authorization of safety and effectiveness.

3. The challenge in development and commercialization

The developer set out to build a prescription-only, cognitive behavioral therapy-based, home-delivered virtual reality therapy. The product needed to reduce pain and the impact of pain on function while being suitable for home use. Key hurdles included ensuring the therapy met rigorous standards for safety and effectiveness to secure FDA authorization, enabling clinicians to prescribe it legally, payers to provide coverage, and patients to access it conveniently in their home environment. Without FDA authorization, payer coverage for such digital therapeutics was unavailable.

4. Strategic regulatory approach through pre-submission engagement

The developer requested a series of pre-submission meetings with the FDA as they developed the optimized product. These meetings allowed the team to leverage both existing and new research to push the boundaries on how to build a virtual reality-based product that delivers meaningful clinical impact. The engagement focused on aligning the product design with patient needs, clinician requirements, payer expectations, and broader public health priorities. Continued collaboration with federal agencies, including the FDA and Veterans Affairs Administration, supported diversification of the portfolio to address conditions such as chronic lower back pain, fibromyalgia, and post-surgical pain through safe and effective non-pharmacological management.

5. Technical and clinical development highlights

The therapy was designed as an in-home virtual reality treatment that is clinically proven to significantly reduce chronic lower back pain. Development emphasized non-pharmacological mechanisms grounded in cognitive behavioral therapy principles. The product was positioned to meet the needs of a home environment while maintaining prescription-only status. Extensive research and iterative feedback from pre-submission interactions helped refine the therapy to ensure it could be prescribed by clinicians, reimbursed by payers, and used effectively by patients without additional interventions.

6. Regulatory and reimbursement outcomes

The product received Breakthrough Device designation and market authorization under the FDA’s De Novo pathway, becoming the first FDA-authorized in-home virtual reality treatment for chronic lower back pain. Patients gained access to the therapy through Veterans Affairs benefits, incurring no out-of-pocket expenses. The Centers for Medicare and Medicaid Services established a virtual reality-specific billing code (HCPCS level II code E1905) and included it in the Durable Medical Equipment medical benefit category for reimbursement. These milestones enabled broad payer coverage and improved patient access.

7. Practical lessons and long-term impact

Pre-submission meetings with the FDA proved essential for developing products that meet patient needs and address critical public health issues. The approach demonstrated the value of early and frequent regulatory engagement, even for innovative ideas that may initially seem outside conventional pathways. The resulting therapy provides a safe, effective, non-pharmacologic option for chronic pain management, reduces reliance on opioids, lowers overall healthcare costs, and supports expanded indications for related conditions. The success establishes a model for future digital health innovations seeking FDA authorization and payer integration while maintaining high standards of clinical evidence and patient safety.