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How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)
Session Chair(s)
Michael Swit, JD
Senior Director, Legal, Regulatory Affairs
Varian, United States
Under the 1976 Device Amendments, new technology that is not substantially equivalent to a marketed device is automatically put in Class III. This session reviews how to get that class switched to a less risky, less expensive regulatory path.
Learning Objective : Discuss how new technology leads to automatic Class III status for a device, even if not risky; Explain how the FDAMA created a new mechanism to avoid automatic Class III status by the de novo petition process; Examine the advantages and burdens of the process.
Speaker(s)
Overview of the De Novo Process
Michael Swit, JD
Varian, United States
Senior Director, Legal, Regulatory Affairs
The De Novo Pathway: Opportunities and Pitfalls - A Petitioner’s View from the Trenches
Michael Drues, PhD
Vascular Sciences, United States
Founder and President
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