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.
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CES 2020: Panel Discusses Health Care In 2040 – Empowered Consumer, Digital Transformation, Data Sharing, Open Source
An expert panel at CES 2020 discussed Deloitte's vision for health care in 2040, with the empowered consumer managing their own health, enabled by a new ecosystem of secure, open access to data and "nudges" to change behaviors. Consulting firm Deloitte foresees outside disruptors dismantling the traditional health-care system, but panelists from Johnson & Johnson and Anthem flexed their muscles.
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.
As the US Food and Drug Administration is developing a new pathway for certain medical software called the precertification program, the agency is asking de novo and 510(k) sponsors to volunteer for a test plan to help the agency in its efforts. At least one expert on the subject is skeptical and says the plan adds burdens without real benefits for sponsors.