Abstract: While there are number of publicly available guidance documents and initiatives from FDA to promote pediatric device development for unique pediatric populations and conditions, there is still an underserved need to ensure that proper scientific and regulatory balance is applied for moderate risk devices. Real world clinical evidence specific to pediatrics, while carrying an important role in meeting pre-market requirements and continued post market requirements for high-risk devices, may become a limiting factor for moderate risk devices. Leveraging existing adult clinical data for extrapolation to pediatric uses for both non-clinical and clinical evidence can play a role by facilitating a thorough assessment of the safety and effectiveness of the device for the pediatric population and will be highlighted through case examples.

Biography: Dr. Iyer earned his BS BME from the University of Mumbai, India, and both his MS and PhD in BME from the University of Southern California. He has 15 years of medical device industry experience at Cook Medical where he is currently Senior Director of Global Regulatory Science for the MedSurg business unit. In this position, Ram is responsible for strategic regulatory and clinical leadership for MedSurg products that represent a broad range of medical specialties and approximately half of Cook’s revenue (i.e., ~$1B annually). He is experienced in guiding complex medical products through various US regulatory pathways (e.g., PMA, HDE, de novo, 510(k)) as well as approval processes in global jurisdictions including Europe, China, and Japan.

~ BME Host: Aaron Lottes ~

*Note:  Dr. Iyer is being considered for a BME Adjunct appointment.