FDA's Device De Novo Reclassification Process

Duration: 90 Minutes
FDA's De Novo pathway is used by the Agency for reclassifying novel technologies into either class I or class II. This webinar will describe the FDA's evolving view of this process, as well as the considerations involved in determining whether it is right for a new product.
Medical Device Compliance
Product ID: 501388
Objectives of the Presentation
  • Applicability of De Novo classification process to low-to-moderate risk devices
  • Understanding the basics of the De Novo classification process
  • Gaining insight into expected De Novo classification review times
  • Best practices for De Novo submissions
  • Evaluate examples of devices brought to market via the De Novo classification process
  • Understand the benefits of the pre-submission process for devices seeking De Novo classification
  • Navigate potential pitfalls in the De Novo classification process
Why Should you Attend
As the De Novo pathway becomes increasingly common for new medical devices, companies must navigate whether it is the right process for their technology and what implications the pathway may have on timing and data requirements. This webinar will provide attendees with the tools needed to assess whether this is the right regulatory pathway for a new product, as well as discuss how to implement the process.

Areas Covered
Attendees will learn:
  • When a de novo reclassification request is appropriate
  • How to use the pre-submission process
  • Developing meaningful risk/benefit arguments to justify a new classification
  • What classification to propose for a new technology
  • The required content and organization for De Novo submissions
  • What special controls to propose
  • How to develop the right supporting data
  • How a successful De Novo process affects future technology
  • How to evaluate and plan for De Novo review timelines
Who can Benefit
  • Regulatory Affairs
  • CEOs and operations managers for small companies
Topic Background
When Congress created the de novo classification process in the Food and Drug Administration Modernization Act of 1997 (FDAMA), the goal was to create an intermediate pathway between a 510(k) submission and a PMA application for innovative, low-risk devices. The purpose was to promote the development and clearance of innovative devices by reducing the regulatory burden.

During the first 15 years after enactment, the de novo process was used infrequently with approximately 76 completed submissions from 1997 until the enactment of FDASIA in July 2012, compared to over 500 PMA applications and 40,000 traditional 510(k) notices over the same time period. In 2012, Congress enacted reforms to the de novo process as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) in an effort to streamline and improve this pathway.
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Instructor Profile:
Yarmela Pavlovic is a Partner in Hogan Lovells' San Francisco office. Her practice focuses primarily on the U.S. Food and Drug Administration (FDA)'s premarket regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices.

Kelliann Payne is Counsel with Hogan Lovells', Philadelphia office. Her experience includes the development, regulation, advertising and litigation of medical devices. Kelliann's work includes drafting premarket submissions for diagnostic and therapeutic medical devices, as well as evaluating applicable regulatory strategies for medical devices.

Lina Kontos is Counsel in Hogan Lovells' Washington, D.C. office. Lina works exclusively on medical device regulatory matters before the FDA, with a focus on the premarket clearance and approval of new medical devices.
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