Implementing a PCCP for Class II SaMD Products Beyond AI/ML

The FDA developed the Predetermined Change Control Plan (PCCP) as a new regulatory framework to manage devices using AI/ML technologies. It would allow manufacturers to obtain pre-clearance or pre-approvals from the FDA for certain types of postmarket software changes without the need for new FDA submissions. Since the initial publication of the PCCP discussion paper in 2019, the federal government passed a bill that expanded the scope of PCCP to cover all medical devices requiring premarket submissions. This white paper is a thought piece to accelerate the full rollout of effective PCCP regulations and guidance, as well as propose key components of the PCCP for Class II SaMD products.