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Home » FDA Clarifies Procedures for Changing an Existing Device
FDA Clarifies Procedures for Changing an Existing Device
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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The draft guidance issued addresses the extent to which an existing 510(k) clearance covers labeling or product changes before a new notification is required.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
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