ATA ACTION APPLAUDS FDA’S FINAL PDURS GUIDANCE, RECOGNIZING STANDALONE SOFTWARE’S ROLE IN IMPROVING DRUG THERAPY AND PUTS PATIENTS AT THE CENTER OF DIGITAL HEALTH INNOVATION

WASHINGTON, DC, OCTOBER 20, 2026 – ATA Action: Advocacy Shaping Virtual Care, the advocacy-focused affiliate of the American Telemedicine Association (ATA), today welcomed the U.S. Food and Drug Administration’s (FDA) final guidance on prescription drug use-related software (PDURS). This landmark guidance marks a meaningful step forward for software that works alongside prescription drugs to improve patient outcomes.

The final guidance makes clear that standalone software, meaning software that is not device-connected, can be included in FDA-required drug labeling when evidence demonstrates a meaningful improvement in a clinical outcome. That recognition was the central ask ATA Action has advocated for since FDA’s 2023 draft guidance. It also gives sponsors the predictability needed to invest in developing and validating software that meaningfully improves how patients use their medicines.

“This is a significant milestone for patients, clinicians, and innovators,” said Lani Reilly, Vice President, Industry Affairs at ATA Action. “FDA got the central architecture right: clinically validated software can meaningfully improve drug therapy without being tethered to a hardware device. We appreciate the agency’s engagement with our community and look forward to continuing to work with FDA, sponsors, and stakeholders as this framework is put into practice.”

Key elements of the final guidance that align with ATA Action’s recommendations include:

• Express recognition of standalone software. FDA defines standalone PDURS functions and confirms they can appear in FDA-required labeling, both when essential to the safe and effective use of the drug and when evidence demonstrates a meaningful improvement in a clinical outcome.
• Clarified device review pathway for standalone PDURS. Depending on the nature of the software, the appropriate pathway will be determined case by case with the relevant review division.
• Clinical benefit as an independent route. Meaningful clinical improvement is recognized as a basis for required labeling for both device-connected and standalone software, addressing concerns that software would need to be “essential” or hardware-connected to qualify.
• A concrete standalone example. The guidance includes a detailed example of a mobile app offering dose reminders, health tracking, and behavioral coaching that demonstrated improved HbA1c when paired with a drug, the type of example ATA Action repeatedly asked FDA to provide.
• New Decision Tree. A new decision tree provides sponsors with a step-by-step framework for determining how and whether their software should be described in the prescribing information.
• Clearer terminology. FDA provides definitions for PDURS, end-user output, and standalone and device-connected functions, and clarifies that “device-connected” describes the data source or connectivity, not whether FDA regulates a function as a device.
• Recognition of real-world evidence. FDA states that adequate and well-controlled studies may incorporate real-world data, as appropriate, to generate real-world evidence.
• Broader use cases and a risk-based approach. The guidance recognizes software that supports individualized dosing, predicts treatment response, and helps manage side effects, within a risk-based framework.
• Protection for follow-on competition. FDA confirms that generic and biosimilar products with PDURS will continue to be evaluated under their established statutory frameworks, consistent with ATA Action’s call to preserve competition.

“ATA and its member companies have collaborated with FDA throughout the development of this guidance, submitting detailed public comments and providing concrete real-world use cases to ensure the framework reflects how manufacturers are actually building and deploying software alongside prescription drugs today,” added Reilly. “We are gratified to see that input reflected in the final guidance and look forward to supporting our members as they move from policy to programs.”

ATA Action will continue to engage with FDA on areas where additional clarity would help innovators and patients, including evidentiary flexibility for lower-risk software, more detailed submission pathways and post approval change expectations, clinician discretion in prescribing, and the treatment of AI-enabled PDURS. ATA Action also continues to advocate for sustainable coverage and payment policy, which is outside the scope of FDA’s guidance but essential to patient access.

ATA Action’s formal comments on the FDA draft guidance here, and the ATA’s PDURS Policy Principles [here]. The FDA’s final guidance is available [here].

About the ATA

The American Telemedicine Association (ATA), the definitive voice for virtual care, is the industry’s trusted community focused on expanding access to healthcare through innovation by advancing education, resources, and policy. Founded in 1993, the ATA represents the most diverse ecosystem in healthcare – including leading health systems, academic medical centers, payers, technology innovators, life sciences companies, and clinician leaders – the ATA delivers clinical standards, policy leadership, education, and evidence frameworks that accelerate high-quality, technology-enabled care.

About ATA Action

ATA Action expands and protects how virtual care is legislated and regulated at all levels of government. Founded in 2022, ATA Action works collaboratively with federal and state legislators and policymakers to influence legislative and regulatory developments in virtual care, digital health, remote patient monitoring, AI in healthcare, health data privacy, private sector healthcare investment, and more. ATA Action represents hospital systems, technology companies, professional associations, direct-to-consumer digital health providers, payers, pharmaceutical manufacturers, digital therapeutics developers, and remote monitoring organizations, and facilitates member-led coalitions focused on initiatives to advance AI in Virtual Care Policy and Cross State Care. ATA Action is a registered 501(c)(6) nonprofit trade organization engaged in lobbying efforts to shape industry-related legislation and serves as an affiliated trade association of the ATA, a 501(c)(3) entity recognized for its leadership in advancing innovation and leading transformation in virtual care.