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Event Details


FDA Approval Process for Medical Devices

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Who should attend?

This seminar is intended for Regulatory, Technical, Clinical and Quality professionals who require an understanding of the FDA medical device approval process. Management, Legal, Medical, Marketing and other professionals who are interested in understanding the key principles of the medical device approval process will also benefit in attending.



This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the “general controls” applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the “pre-submission” process, which FDA strongly recommends prior to the initial submission of novel devices to help ensure a successful submission process. Finally, some “hot topics” will be presented. Depending on the interest of the participants, these may include new FDA requirements and policies involving Unique Device Identifier, regulation of device software, and how to distinguish device “enhancements” from being considered a recall, and device reprocessing guidance.


Upon completion of this seminar, participants will:

  • Know how the FDA is organized
  • Learn how to determine the classification of your device
  • Demystify the 510(k) clearance process
  • Understand the de novo and other options when there is no predicate device
  • Determine when FDA approval is needed for a clinical study
  • Learn how to obtain an IDE for an investigational device
  • Navigate the PMA approval process
  • Plan for a pre-submission meeting with the FDA
  • Understand the FDA’s review performance goals and time frames




Leigh White

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