FDA To Update Clearance Procedures For Medical Devices

On November 26, 2018, the U.S. Food and Drug Administration (FDA) announced it was updating its 510(k) program clearance procedures for medical devices to ensure that new medical devices account for advances in technology or demonstrate that they meet more modern safety and performance criteria. The FDA intends to modernize the program by using more modern comparison devices, which are called predicate devices.

In early 2019, the FDA intends to finalize guidance establishing an alternative 510(k) pathway to be called the “Safety and Performance Based Pathway.” The alternative pathway will allow manufacturers of certain device types to . . .