The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support manufacturers of MLMDs by reducing the regulatory burden of reassessment following certain changes and updates to their devices.
Building on the 10 guiding principles for Good Machine Learning Practice, the five guiding principles for MLMD manufacturers outline that a PCCP must be…
