SILVER SPRING, Md. – Dr. Scott Gottlieb, commissioner of the U.S. Food & Drug Administration, recently revealed the agency’s plans to establish a more efficient approach to digital health device regulation—and industry experts are cautiously optimistic.
“The streamlined certification process is a step in the right direction,” said Xu Zou, CEO of Internet of Things security software provider ZingBox.
Gottlieb’s Digital Health Innovation Plan calls for the government to establish public health policies that are clear enough for developers to apply on their own, without having to seek out the FDA’s position on every technology change or software development on a case-by-case basis.
“Smart devices make streamlining the FDA’s approval process a necessity,” said Jacques Touillon, CEO and co-founder of Airboxlab, maker of smart air quality monitoring devices.
“The current system worked when changing the function of a device meant shipping a whole new product, but today developers can add entirely new features to a product as it sits on a user’s nightstand, simply by updating the software over the Internet,” he said.
In his blog post that laid out the new plans, Gottlieb said the FDA will establish guidelines specifying the boundaries around low-risk technologies like some mobile health apps and clinical administrative support software. In addition, the agency will add other technologies that could be considered low-risk.
The commissioner also described a new third-party certification pilot program, still under development, under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA premarket review.
Zou said that while the FDA’s plans may help streamline the certification process, device security must be a top priority.
“History has shown that where new features and innovation go, so do the hackers and malware,” he said. “As the requirements of FDA certification relaxes, device manufacturers and health care providers must plan for the additional security needed to protect the more feature-rich devices.”