FDA Launches Device Software Pre-certification Pilot

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running — and companies can apply to take part in the program on August 1.

FDA Commissioner Scott Gotlieb, who announced the pilot’s formal launch, said the agency wants to lower regulatory hurdles and encourage innovations, noting healthcare has been slow to adopt disruptive technology tools like digital devices.

“We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions,” he said.