Recording of a Learn and Connect event sponsored by Children's Hospital of Philadelphia Innovation Ecosystem
The process of FDA classification and regulation can be time-consuming and confusing for inventors and researchers working to bring medical devices to market.
In this Learn & Connect event, Dr. Jason Van Batavia - a CHOP pediatric urologist, Academic Entrepreneurship chapter author, and co-creator of the UroGenie - reviews how to
Determine what is considered a medical device and differentiate between medical device classifications, as defined by the FDA.
Distinguish between FDA regulatory pathways for medical devices and discern which pathways to consider based on device classification.
Pediatric Urologist, Children’s Hospital of Philadelphia
Assistant Professor of Urology in Surgery, Perelman School of Medicine
Co-Creator of the UroGenie