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FDA’s New, Proactive Digital Health Innovation Plan Will Bring Increased Innovation, Greater Choice and Lower Prices, Says CTA

Arlington, VA – June 21, 2017 – 

The following statement is attributed to Julie Kearney, vice president of regulatory affairs, Consumer Technology Association (CTA), regarding Food and Drug Administration (FDA) Commissioner Scott Gottlieb’s, MD announcement of intent to pursue a Digital Health Innovation Plan to foster innovation at the intersection of medicine and digital health technology:
“We appreciate the FDA’s efforts to establish clear rules that will promote continued advancements in innovation that meet  consumers’ demand for healthy lifestyles. The FDA’s anticipated, new pilot program to create a third-party certification program will transform market access, while helping innovative companies deliver  lower prices and greater choice to American consumers. Developers now can expect a quick and flexible approval of digital innovation without sacrificing quality and effectiveness.  
“The FDA’s focus on the review of higher-risk products will allow innovators to navigate a modern-day regulatory process more easily, so digital health care can evolve and advance quickly and responsibly. 
“We look forward to continuing to work with the FDA to enable technology and innovation help more and more Americans live healthier, safer and more efficient lives.”
The FDA’s latest regulatory guidance for digital wellness apps and low-risk fitness trackers is a continuation of the agency taking steps to improve Americans accessibility to wearable health solutions. Last year, the FDA announced its commitment to creating a category for over-the-counter hearing aids. Now, Congress has included in the FDA User Fee Reauthorization bill an amendment that would allow the FDA to create the category. CTA is supportive of the provision and is running a grassroots campaign urging consumers to share their support for over-counter hearing aids with legislators.  
CTA projects U.S. unit sales of all wearable tech devices will reach 48 million units in 2017 (a 14 percent year-over-year increase) and earn $5.5 billion in revenue (a three percent increase).