Path for Low-Risk Medical Devices Eased Under FDA Final Rule

Device makers will have a more efficient pathway for getting new, low-risk equipment on the market under a final rule released Monday.

The rule (RIN 0910-AH53) from the Food and Drug Administration lays out the procedures and criteria for manufacturers to ask for their devices to be reviewed under the de novo process, which is one of several ways to put a device on the market.

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 ...