Continuous Learning: FDA Looks to Wider Adoption

Regulatory Focus (03/27/2019) Mulero, Ana

Agency-wide adoption of advanced continuous learning for regulatory processes is gaining momentum via the efforts of the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). In a recent keynote discussion, FDA Principal Deputy Commissioner Amy Abernethy detailed how CDRH projects and other initiatives apply continuous learning. She said CDRH reviewers are striving to guarantee their skill with a new product continues to increase after it reaches the market, citing the National Evaluation System for health Technology (NEST) as a motivator. NEST is engineered to facilitate continuous learning within CDRH by offering a real-world evidence (RWE) innovation safety net, and it is currently accepting requests for use of its data network. CDRH's cultivation of continuous learning has informed RWE initiatives across the agency's centers and offices. Abernethy also noted that CDRH's continuous learning strategy has wide applicability throughout FDA. She said it delivers "the microcosm of how we think about using data in a continuous fashion to continuously monitor how a medical product is performing," as well as a "forward-looking view of where this whole space is going because it is uniquely set up to be able to do this work."

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