ARTICLE SUMMARY:
A infographic look at FDA's use of Predetermined Change Control Plans.
How many Predetermined Change Control Plans has FDA authorized? Through which premarket pathways? And what types of device changes have been allowed by the agency to go forward without a new submission? Answers to those questions are below. And for more context and real-world examples of PCCPs, see “The PCCP Picture: Iterating AI, Device Compatibility, Design, and Beyond.”
