FDA’s Device De Novo Reclassification - Webinar CD/Transcript
FDA’s Device De Novo Reclassification
Is the de novo process right for your medical device?
To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar on Feb. 9 that will explain the de novo procedure and tell you what you must do to ensure that your request includes all the data elements and supporting research the FDA requires.
Attend this session and our three expert de novo attorneys from Hogan Lovells will quickly bring you up to speed. You'll get the details of the key issues surrounding the process:
- FDA’s evolving view of substantial equivalence and de novo reclassification
- When a de novo reclassification request is appropriate
- When and how to use the pre-submission process
- Making effective risk/benefit arguments that will pass FDA muster
- How the shift in timelines for review could affect your lifecycle planning and subsequent launch plans
- What happens after an initial de novo clearance, both for subsequent modifications and for competitive products in the same classification
- And more
Specifically, you'll learn the key elements (and nuances) that will significantly improve your chances of getting your device cleared on its first review, including key questions you must answer and information you must include in your request, such as:
- Should the device be regulated as Class I or Class II?
- What must be included in the proposed special controls document
- Supporting protocols and data
- Summary of benefits and potential risks
- Risk and mitigation information
And, you'll find out what to say in the all-important “classification summary” that shows you have thoroughly researched the legally marketed devices and concluded that no appropriate predicate exists.
Now that the one step de novo process has been in action for some time with devices cleared via the direct de novo pathway, find out about best practice tips and tricks to get your products to market more quickly. Take full advantage of it. Sign up for this invaluable update on the new and improved de novo clearance process.