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U.S. Department of Health and Human Services

Science & Research

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CDRH's Experiential Learning Program


CDRH offers an innovative learning opportunity for new and experienced review staff. The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.  Because technology continuously evolves, it is essential that CDRH review staff members are aware of and understands how medical devices are developed, clinically tested, manufactured, and used.

Learning Outcomes:

  • Gain Awareness of Existing, Emerging and Innovative Medical Device Technologies
  • Transfer Knowledge to Application Review
  • Improve Critical Thinking and Problem Solving

Purpose: To provide real-world knowledge of products that CDRH regulates, by learning from the medical device industry, the clinical community and academic stakeholders, to improve the pre-market review process.

Key Elements: The ELP encompasses two areas:

  • Site visits: ELP participants will visit local and long-distance sites to acquire real-world knowledge of emerging products encountered in the pre-market review process. CDRH has partnered with device manufacturers, academia, research and the clinical community to provide experiential opportunities in a range of settings.
  • Evaluation: Feedback is essential to continually improving and growing the ELP. ELP participants are expected to provide feedback on their experience following each site visit. Additionally, they will complete an overall program evaluation after participating in the full rotation of site visits.

Benefits: The ELP will expand reviewers’ knowledge of emerging and innovative products in multiple environments and enable them to more effectively apply that knowledge when reviewing medical device submissions. Ultimately, ELP will advance FDA’s mission to promote and protect the public health by improving the pre-market review process.

 
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