Navigating FDA guidance on managing iterative post-market modifications in AI-enabled medical devices.
An FDA-cleared PCCP comprises three essential sections: the Description of Modifications (precise algorithm parameters eligible for retraining), the Modification Protocol (verification and validation procedures), and the Impact Assessment (risk evaluation). ClinicalSoftwareAI enforces these boundaries in code.
When new hospital training data is ingested, the platform automatically triggers end-to-end regression suites, verifying that diagnostic sensitivity does not degrade across any clinical subgroup before deploying updated weights.