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…

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe