Faster Approval for Novel Medical Devices Envisioned Under Guidance

More lower-risk devices could get to market sooner under proposed regulations released by the FDA Dec. 4.

The Food and Drug Administration’s proposed rule would for the first time establish submission requirements and review procedures for novel devices under the agency’s de novo classification program.

The de novo program allows a device that does not have a predicate, or previously approved comparative device, to be designated as a lower-risk class I or class II device, which would mean a quicker and easier path to approval. Before the de novo program was created in 1997, all new devices that lacked a ...