Device De Novo Reclassification - Webinar CD/Transcript
Device De Novo Reclassification: FDA’s New Direct De Novo Petitions in Action
Is the de novo process right for your medical device?
To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar CD and transcript that explains the new one-step de novo procedure and tell you what you must do to ensure that your petition includes all the data elements and supporting research the FDA requires.
Our three expert de novo attorneys from Hogan Lovells' Philadelphia office will quickly bring you up to speed. You'll get the details of the key issues surrounding the new process:
- FDA’s evolving view of substantial equivalence and de novo reclassification
- When a de novo reclassification petition 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 petition, such as:
- Should the device be regulated as Class I or Class II?
- Is it subject to 510(k) requirements?
- 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.
With the new one-step process, the FDA is finally offering you a tantalizing opportunity to get your products approved and to market more quickly. Take full advantage of it. Order this invaluable update on the new and improved de novo clearance process.