FDA Clarifies Procedures for Changing an Existing Device

FDA is shedding some light on when changes made to a cleared device necessitate a new 510(k) premarket notification.

The draft guidance issued addresses the extent to which an existing 510(k) clearance covers labeling or product changes before a new notification is required. A companion document covers the same subject for software changes.

The guidance uses flowcharts with questions to simplify the process of determining whether a change mandates a new filing. There are six series of charts, each focusing on separate issues that manufacturers may face. — Joya Patel