DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

戻る Agenda

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

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)

Session Chair(s)

Michael Swit, JD

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

The De Novo Pathway: Opportunities and Pitfalls - A Petitioner’s View from the Trenches

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