Working Within Regulatory Boundaries to Win in Medical Product Development
This workshop will discuss the regulation of investigational medical products by the U.S. Food and Drug Administration (FDA). It will give an overview of FDA's role in regulating medical products and it will offer guidance on how to classify your product and determine the regulatory requirements that apply. The workshop will offer a deeper dive into medical devices, discussing marketing pathways and the application process for clinical studies using unapproved devices. Case scenarios will be presented to enhance learning and stimulate audience participation. This workshop will address the following questions (and more): 1) How does the FDA regulate medical products?, 2) Is my product a drug, device or biologic?, 3) How do I classify my medical device?, 4) What is FDA's approach to regulating the commercialization of medical devices?, 5) What are the benefits of a pre-submission meeting with the FDA?, 6) What is the difference between an abbreviated and "full" IDE and when is the "full" IDE applicable?, 7) What information needs to be included in an IDE?
Zoom link provided upon registration.