Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review.
In a proposal unveiled Nov. 19, FDA outlined a path that treats software as promotional material if a company doesn’t plan to claim it as necessary for the safe and effective use of a product (see BioCentury Extra, Nov. 19). Such material must be submitted to FDA at the time it is distributed, but in most cases does not require approval or clearance.
The proposal represents FDA’s first attempt to integrate digital health, which has been handled by the Center for Devices and Radiological Health, into drugs and biologics reviews.
The goal, FDA Commissioner Scott Gottlieb told BioCentury, is to clear regulatory ambiguity preventing biopharma companies from embracing mobile and other digital technologies. “The technology is ubiquitous, and I think this industry’s been slow to leverage it in large measure because of the regulatory uncertainty.”
Low-hanging fruit, Gottlieb said, includes digital tools to help improve adherence to therapies, track and communicate symptoms to physicians, and collect data that physicians can use to make treatment decisions such as dose adjustments.
“There is a lot of interest in the industry in developing these tools, and I think that these tools can help promote better healthcare,” he said. “They can promote compliance, promote collection of information