Fundamentals of the de novo process for medical devices: What you need to know when pursuing a de novo application and approval with the FDA 2017

Topics

• What is the definition of de novo? A brief history of the medical device regulations with respect to section 513 of the FD&C Act (device classification system) Description of the de novo process (section 513(a)(1)) and the two pathways used to pursue FDA approval Links to FDA guidance documents available and other useful references Best practices and helpful hints to help facilitate the de novo process and submit a good quality application

Who should Attend

• Regulatory Affairs Managers
• Medical Device Professionals
• Small Business Owners who will be submitting a device for approval with the FDA
• Corporate Device Managers responsible for submitting medical device applications for new devices or for new indications for use
• Regulatory Consultants