Medical device regulators at the US Food and Drug Administration has commenced a new pilot program for expanded suitable in the agency’s Special 510(k) pathway, prospectively relieve market compliance necessity for more manufacturers whose devices have undergone into changes.
FDA’s Special 510(k) Program Pilot would authorize more types of changes to the registered devices to qualify for the simplified Special 510(k) pathway, planned for simplified regulatory clearance of changes to devices that have already obtained premarket notification. All the Special 510(k) submissions to FDA from October 1, 2018, will be examined for addition in the pilot, with the goal of increasing overall utilization of this 510(k) route.
Read More: US FDA Sets Pilot to Expand Special 510(k) Market Pathway
operonstrategist.wordpress.com 