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

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.

US FDA plans to experiment with its digital pre-certification pilot program over the next year and will update stakeholders depending on what the agency learns, according to FDA’s top official on digital health.

FDA has been developing the pre-cert program over the past year and a half, and recently fully launched a pilot program to evaluate nine participating companies including several major multinational...

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