LTR 64: Opportunities and challenges to leverage PCCP for speed to market

Summary

“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”.

PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA.

In this episode, Yu Zhao explains how the PCCP tool offer…

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