The 21st Century Cures Act establishes a program for “breakthrough” devices, exempts some categories of medical software from regulation as a medical device, and requires the FDA to publish a list of reusable device types that must include usage instructions and cleaning data.
Section 3051 of the act requires the FDA to establish a program to speed up development of devices featuring breakthrough technologies that are designed to diagnose or treat serious conditions and have no approved or cleared alternatives. To participate in the program, a device must offer significant advantages over existing devices.
A sponsor may request priority review from the FDA at any time before submitting a device to the program, and the agency must respond within 60 days. The program builds on the FDA’s Expedited Access Pathway, chiefly by permitting access to 510(k) devices. — Jeff Kinney