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Clinical Trial Events
SOCRA 18th Annual Device Research & Regulatory Conference

Workshop Preconference Workshop: Device Basics track

Preconference: Overview of Premarket Submissions, Selecting, Preparing and Submitting the Application in the Correct Pathway

Wed, Apr 23, 2025 · 3:20–4:20 PM PDT Hyatt Regency Newport Beach

About this session

Several types of premarket submissions can be submitted to CDRH. In order to legally market a device in the US, the most common forms of premarket submissions to CDRH are the 510 (k) premarket notification submission, the PMA premarket approval and the De Novo Reclassification. This session will provide an overview of the various marketing pathways and discuss some best practices and strategies for submitting a premarket application.

Speaker

  • Donna Headlee

    Retired Branch Chief, Premarket Programs Branch, Division of Industry and Consumer Education, CDRH · Food and Drug Administration

    Instructor