The following statement is attributed to Julie Kearney, vice president of regulatory affairs, Consumer Technology Association (CTA), regarding the Food and Drug Administration’s (FDA) announcement of its Digital Health Innovation Action Plan and launch of a Software Pre-certification Pilot Program.
 
“The FDA’s new approach allows the federal government to keep up with the fast pace of innovation, while preserving consumer safety. Under the FDA's new program, American innovators will have greater flexibility to create the health and wellness tech solutions that are already, and more accurately, monitoring personal health, and help doctors to treat patients more efficiently.
 
“The pilot program, especially, is a significant step forward – a more streamlined, FDA pre-market review process of certain types of digital health products will deliver technology breakthroughs to patients even sooner. And the FDA’s latest guidance for digital wellness apps and certain fitness trackers is a continuation of the agency taking innovative steps to improve Americans’ accessibility to wearable health solutions.
 
“We look forward to continuing to work with the FDA on this opportunity to embrace the life-changing benefits that technology delivers.”
 
CTA projects U.S. unit sales of all wearable tech devices will reach 48 million units in 2017 (nine percent year-over-year increase) and earn $5.56 billion in revenue.