DTA Releases & Statements

Digital Therapeutics Alliance To Support and Provide Guidance for FDA’s Software Pre-Certification Program

December 18, 2017

ARLINGTON, Va., Dec. 18, 2017 /PRNewswire/ — The Digital Therapeutics Alliance (DTA), the pre-eminent industry organization for digital therapeutic approaches, is leading an initiative to support the development of the U.S. Food and Drug Administration’s (FDA) Software Pre-Certification Program. FDA’s program embraces the principle that certain digital technologies provide significant benefits to patients’ lives by helping them manage chronic conditions outside of traditional healthcare settings, as well as supporting providers, healthcare systems, and payers by facilitating disease prevention, diagnosis, and treatment.

The Pre-Certification Program will enable FDA to certify companies that design and manufacture regulated digital health solutions with a demonstrated culture of quality and organizational excellence through a robust certification process suited for the iterative software design, development, validation, and maintenance processes.

As part of DTA’s interaction with the FDA, the industry group will propose a comprehensive overview of how the Pre-Certification Program may be developed, operated, and scaled to achieve its goals. DTA member companies will draw on their collective regulatory and clinical-validation expertise to provide the Agency with an industry-level perspective for establishing the necessary program frameworks, key performance indicators, and benchmark criteria.

“Our Alliance supports FDA’s approach to designing a regulatory framework that accommodates the distinctive nature of digital technology, its clinical value, unique and impactful user interfaces, and our industry’s compressed commercial cycle for introducing new products to market,” said Pierre Leurent, CEO, Voluntis, and DTA Chair. “This collaboration with the FDA is designed to foster and stimulate innovation, while ensuring individuals using digital therapeutics have access to high-quality, safe, and effective options for managing and treating medical conditions.”

Digital therapeutics are clinically-validated solutions that may be used as standalone direct treatments, or in association with other treatments to improve the overall quality, cohesion, outcomes, and value of healthcare delivery. Digital therapeutics demonstrate safety and efficacy in randomized control trials, receive regulatory clearance when used as a medical device, integrate into clinical practice, and are tailored to patients’ clinical needs, goals, and lifestyles.

“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-Certification Pilot Program,” said Bakul Patel, Associate Director for Digital Health in the FDA’s Center for Devices and Radiological Health. “This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”

About the Digital Therapeutics Alliance
The Digital Therapeutics Alliance (DTA) represents the healthcare industry’s leading manufacturers of clinically validated digital therapeutic (DTx) solutions. DTA members – including patients, healthcare providers, payers, academic institutions, technology organizations, and pharmaceutical manufacturers – collaborate to enhance patient outcomes through assessing the value and impact of DTx solutions in clinical practice, constructing industry and regulatory frameworks, and encouraging data-driven integration and utilization of DTx solutions across the healthcare industry. Founding members include Akili Interactive, Propeller Health, Voluntis, and WellDoc. Learn more: www.dtxalliance.org



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