Description: Working with FDA: Factors for Successful Approval In the US, a high percentage of FDA medical device submissions fail: 1 in 5 for 510(k)s and PMAs; more than half of De Novos. Failed submissions mean the loss of significant amounts of time, money, and resources that are spent developing a medical device and drug device combinations. This series of talks aims to provide participants with several key success factors to increase submission success. Regulatory Intelligence applied during the development and review process offers an opportunity for improving regulatory performance. In addition, manufacturers must have a clear understanding of clinical requirements and accordingly design clinical development plans and safety and efficacy assessments. For combination products, in vitro assessment as well as threshold analysis and human factor studies in relevant populations and use settings are needed to evaluate the ease of use and reduce error rates etc. This session will also help participants in learning critical aspects to be considered in clinical assessment, including designing human factor studies and applying foreign clinical trial data for US submissions.
• Regulatory Intelligence to Overcome Challenges in FDA Reviews: A Practical Guide for Medical Devices; Melissa Walker; President & CTO Graematter, Inc • Critical role of clinical assessment and human factor studies in Medical Device Development; Deepa Arora; Director- CLINEXEL Life Sciences Private Limited • Considerations for use of non-US clinical data in medical device FDA submissions; Jason Krzeszak; Principal Product Development Strategist; NAMSA
understand FDA’s position on acceptability of OUS clinical data for submissions
identify opportunities to strategically use clinically applicable data from studies conducted outside of the US (OUS) for use in product development plans and US regulatory strategies
identify risk mitigation strategies to avoid costly mistakes in clinical development plans that leverage patients enrolled outside of the US