The FDA recently released a new case study entitled “De Novo Pathway for Medical Devices: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device.”

The case is part of the National Medical Device Curriculum, which is a learning tool for academic institutions and science and technology innovators to advance their knowledge of FDA’s medical device regulatory processes. It comprises of a series of fictional case studies based on real-world medical device scenarios, in a format similar to Harvard Business School Case Studies.