FDA Publishes 5 PCCP Principles For ML Devices In Collaboration With Canada And UK

Five principles recently published by the US Food and Drug Administration in collaboration with Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), are laying the foundation for international harmonization of regulations for pre-determined change control plans (PCCP) for machine learning-enabled devices.

PCCPs allow a regulatory body to approve in advance the changes a company plans to make to their device postmarket to keep the products safe, effective and up to date....