The US FDA medical device classification scheme presents some unique challenges for new technology. With a system based on equivalence, manufacturers of new and novel devices face a rigorous market entry process usually reserved for high-risk, Class III devices. However, some novel devices qualify for the FDA de novo process, which allows products to enter the market as Class I or Class II depending on their risk to users and patients.
In this webinar, Audrey Swearingen, RAC will discuss the benefits and criteria of the US FDA de novo program and how qualifying device companies can pursue this pathway to the US market. You will learn:
• What is the de novo process?
• How to determine if it is applicable to your device
• Communicating with the FDA via the Pre-Submission program
• Content of a de novo application
• FDA review process
ABOUT THE PRESENTER:
Audrey Swearingen, RAC (US) is the Regional RA Manager at Emergo by UL’s Austin, Texas headquarters. With over 20 years of experience in medical device regulatory affairs, Audrey’s areas of focus include US FDA device premarket registration, device labeling and promotion compliance, and risk assessment. Other areas of expertise include FDA human tissue regulations, as well as European CE marking and Canadian device license applications.