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CDRH Will Experiment With Pre-Cert Pilot Participants To Figure Out Right Metrics, Processes

Executive Summary

With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.

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