Tuesday April 23, 2013 at 9:00 AM EDT
Wednesday April 24, 2013 at 1:00 PM EDT

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UMBC Research Park, Catonsville, MD 
5520 Research Park Drive
Suite 100
Catonsville, MD 21228

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Mary Gordon 

FDA's Pre-Submission Guidance for Medical Devices 

FDA’s Pre-Submissions Guidance for Medical Devices

Dates: April 23-24, 2013

Instructors – Elisa Harvey DVM, PhD and Semih Oktay, PhD, CardioMed Device Consultants LLC

This 1 day seminar will focus on FDA’s recently issued Draft Pre-Submissions (formerly the Pre-IDE program) Guidance Document.  This highly practical, advanced course is intended for R&D, regulatory, and technology development professionals who have some familiarity with the pre-IDE process, as well as for emerging medical device companies.

Participants will learn:

  • What this guidance document means to the regulated industry and the regulatory process for medical devices.
  • How to integrate the pre-submission process and potential outcomes into your product risk assessment and development process at the optimal time.
  • Specific examples that illustrate how to ensure the best possible outcome, and avoid pitfalls and common mistakes.
  • About templates and sample timelines for each pre-submission category.

As medical devices and the paths to market have become more complex, it has become even more critical for companies to minimize wasted effort, time and resources, which often occur due to a misuse of and/or lack of understanding of how and when to best take advantage of CDRH’s Pre-Submission processes and recommendations.   Utilizing this process to your best advantage by clearly understanding FDA’s expectations can help to avoid significant problems later in the device development process.

Space will be limited to 40 participants, and CardioMed clients registered by December 14, 2012 will receive discounted registration and priority admission.  FDA will be invited to present an update, and registration also includes a private, complimentary 20 minute consultation to discuss your current project with Dr. Harvey and Dr. Oktay, hosted at the CardioMed offices on the afternoon of the second day. Certificate of attendance, networking breaks, lunch, and reception, as well as course materials, are also included.


Call or email Mary Gordon at 503 914 6360, mary.gordon@instituteofmdd.com for more information.