Description: Reclassification of a medical device can be a strategic advantage to an organization faced with known changes on the horizon, such as a change in legal or physical manufacturer. Regulatory pathways for Class II and Class III devices in the US are dramatically different with longer review times. By thinking strategically in light of known business decisions, this allows for agility and less impact to the business. This session will include a case study in the down classification of a Class III accessory to a Class II accessory through the Q-sub process, alignment with the FDA, and following up with a Traditional 510(k) to baseline the device moving forward.
Learning Objectives:
Upon completion, participants will be able to consider creative strategies for their own devices to be more nimble in a regulated environment.
Upon completion, participants will be able to utilize the Q-Sub process to align with FDA on regulatory strategy.
Upon completion, participants will be able to align strategic imperatives with leadership.