The purpose of this document is to share high-level principles on the use of PCCPs as a way of authorizing certain planned medical device software modifications for which regulatory authorization is otherwise required. Additionally, it aims to identify the elements that manufacturers may consider when developing and documenting a PCCP to support regulatory review. The document outlines a broad, but harmonized framework for PCCPs, allowing each jurisdiction to apply the concepts within the scope of regulations applicable to their jurisdiction.
This document is intended to:
1. Identify essential principles for developing a PCCP for medical device software;
2. Establish the elements of a PCCP for modifications to medical device software;
3. Highlight the scope of changes that could be considered within the bounds of a PCCP; and
4. Highlight the benefits and challenges of PCCPs for users, regulatory bodies, and manufacturers.