Food and Drug Administration (FDA) Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices
Summary
In August 2024, FDA issued draft guidance, which provides FDA’s current thinking on Predetermined Change Control Plans (PCCPs) in a marketing submission for a device. A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed. They are designed to limit how often developers need to seek FDA review of device modifications, which is especially helpful in the context of ever-evolving AI-enabled medical devices. This version of the guidance fills in some gaps left in a previous version issued in April 2023.
Impacted Sectors
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