Hardware Podcasts

#389: Pre-determined Change Control Plans

Global Medical Device Podcast · 31 Oct 2024 · 44m · Episode 389

What this episode covers

Mike Drues, President of Vascular Sciences and former FDA consultant, discusses the Predetermined Change Control Plan (PCCP) with host Etienne Nichols. Drues explains how PCCPs allow manufacturers to get pre-approval for anticipated device changes within their original 510(k) or PMA submissions, a framework originally designed for AI-based Software as a Medical Device (SaMD) but now expanded to all medical devices. He highlights the regulatory logic behind pre-validating boundaries for changes, using examples like 3D-printed knees and in vitro diagnostics, while cautioning that the process requires significant upfront data and may not always save time or money compared to traditional special 510(k) submissions.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 510(k), PMA, SaMD

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