FDAnews
Falls Church, VA (PRWEB) October 28, 2014
Device De Novo Reclassification:
FDA’s New Direct De Novo Petitions in Action
**FDAnews Webinar**
Nov. 20, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DeNovoReclassification
Is the de novo process right for a particular medical device?
Perhaps.
To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar on Nov. 20 that will explain the new one-step de novo procedure and tell manufacturers what they must do to ensure that the petition includes all the data elements and supporting research the FDA requires.
Attend this session and our three expert de novo attorneys from Hogan Lovells' Philadelphia office will quickly bring manufacturers up to speed. Attendees will 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 the 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, attendees will learn the key elements (and nuances) that will significantly improve the chances of getting the device cleared on its first review, including key questions that must be answered and information that must include in the 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, attendees will find out what to say in the all-important “classification summary” that shows the manufacturer has thoroughly researched the legally marketed devices and concluded that no appropriate predicate exists.
With the new one-step process, the FDA is finally offering a tantalizing opportunity to get products approved and to market more quickly. Take full advantage of it. Sign up for this invaluable update on the new and improved de novo clearance process.
Meet the Presenters:
Jonathan Kahan is a partner and co-director of Hogan Lovells Food, Drug, Medical Device, and Agriculture group and has been practicing in FDA law for 40 years. His practice focuses primarily on assisting medical device companies in navigating the FDA regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices and biologics.
Janice Hogan is the Managing Partner of Hogan Lovells' Philadelphia office and is co-director of their FDA/Medical Device practice. She focuses her practice primarily on the representation of medical device, pharmaceutical and biological product manufacturers before the U.S. Food and Drug Administration (FDA). She is a biomedical engineer and focuses on regulatory counseling related to high technology medical products.
Lina Kontos is an associate at Hogan Lovells US LLC based in Washington D.C. Lina works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing clearance and approval for their devices. She assists companies in matters pertaining to product development, regulatory strategy and product submissions, as well as providing advice on a variety of other device-related regulatory issues including issues related to wireless technology, advertising and promotion.
Who Will Benefit:
- Regulatory affairs professionals
- Product lifecycle managers
- Approval and submissions specialists
- Medical affairs
- Personnel new to the industry
Webinar Details:
Device De Novo Reclassification:
FDA’s New Direct De Novo Petitions in Action
**FDAnews Webinar**
Nov. 20, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DeNovoReclassification
Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
Online: http://www.fdanews.com/DeNovoReclassification
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.