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 ½ 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:
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, firstname.lastname@example.org for more information.