LTR 64: Opportunities and challenges to leverage PCCP for speed to market
Let's Talk Risk! with Dr. Naveen Agarwal · Naveen Agarwal, Ph.D.
October 31, 202429m 31s
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Show Notes
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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