Calls for consistent, predictable, and innovation-friendly regulatory framework for digital health technologies
WASHINGTON, DC, NOVEMBER 7, 2025 – ATA Action, the advocacy arm of the American Telemedicine Association (ATA), expressed enthusiastic support for the U.S. Food and Drug Administration’s (FDA) draft guidance for Prescription Drug Use Related Software (PDURS) and submitted comprehensive comments on the proposed framework.
“We view the PDURS initiative as both de-regulatory, because it supports the pairing of software and drugs without the constraints of the traditional combination product framework, and deflationary, because it can allow for more effective, integrated solutions without added cost to the healthcare system. This initiative has our full and enthusiastic support,” said Andy Molnar, head of digital health at ATA Action. “PDURS will transform healthcare delivery by aligning the interests of all stakeholders around what matters most, patient outcomes, and empower providers to deploy these solutions to patients, at their discretion, without adding cost or administrative burden.”
Read the ATA Action Comment Letter to FDA.
In a detailed comment letter to the FDA, ATA Action outlined specific changes to the final guidance to better reflect the Agency’s original goals for the PDURS framework and align with the approach being taken by pharmaceutical manufacturers and digital health companies, covering three key areas:
- Reflect industry consensus that most PDURS solutions will be standalone software rather than combination or device-connected software: The final guidance should revert to 2018 framework language to avoid unnecessary ambiguity about how these solutions can be appropriately reviewed by FDA as standalone software supported by adequate evidence of clinically meaningful benefit.
- Capture the de-regulatory intent of the 2018 PDURS Framework in final guidance: FDA should revert to the more flexible 2018 framework language, which appropriately focused on whether sponsors provide substantial evidence of a clinically meaningful benefit, and allow greater flexibility in evidence generation.
- Reduce ambiguity: The current draft guidance leaves critical questions unanswered and creates uncertainties that will slow adoption and discourage investment in PDURS solutions. FDA should better define key terminology and provide clearer direction regarding early engagement with the FDA on PDURS, evidence requirements, and submission options for both the software output and the software itself.
“These proposed refinements will ensure that the PDURS guidance provides a consistent, predictable, and innovation-friendly regulatory framework while maintaining FDA’s high standards for safety and efficacy,” Molnar added. “PDURS will fundamentally change how patients interact with their pharmaceutical drugs, in a future where there will be a PDURS position for every drug.”
Prescription digital therapeutics are software programs granted market authorization by the FDA to evaluate, diagnose, manage symptoms, or treat an illness, injury, or disease – either alone or in combination with other treatments – including substance and opioid use disorders, mental health, women’s health, cancer, stroke, diabetes, MS and other chronic conditions. PDTs are available 24/7 on mobile phones, tablets, smartwatches, or laptop computers. The first prescription app received FDA clearance in 2010 for diabetes management. The number of PDTs has since increased rapidly, with new products in development, including treatments for Alzheimer’s disease.
“ATA Action has convened prominent leaders in PDURS to leverage their combined expertise and vision and presented industry consensus at an FDA listening session earlier this year, while successfully engaging key members of Congress, to create guidance that best reflects the evolving role of digital health technologies in drug development and patient care,” added Molnar, a member of the FDA’s Digital Health Advisory Committee.
About ATA Action
ATA Action recognizes that telehealth and digital health have the potential to transform the healthcare delivery system by improving patient outcomes, enhancing the safety and effectiveness of care, closing gaps in care delivery, and reducing costs. ATA Action acquired the Digital Therapeutics Alliance in March 2025, creating an inclusive platform for policy and advocacy, and ensuring that telehealth and digital therapeutics remain integral components of the U.S. healthcare system. ATA Action is a registered 501c6 entity and an affiliated trade organization of the American Telemedicine Association (ATA).