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browse by categories     Audio Conference Archive     Audio Conferences     Past Conference Documentation     Webinar Archive     Webinars     Workshops product FDA De Novo Process for IVD Companies This product was added to our catalog on Monday 21 September, 2009. Item #: Price:  $395.00    Product description 60 Minute Webinar Recording Speaker Kathleen Simon, Ph.D Reviewer, Microbiology Division, Office of In-Vitro Diagnostics/Center for Devices and Radiological Health, FDA The De Novo Process is the evaluation of automatic class III designation of devices. Using the De Novo Process could allow companies to submit a 510(k) for a new IVD that would otherwise have to get to the market via the PMA Process. This webinar will give an overview of the De Novo Process, discuss when it should be used, and give an FDA perspective on the advantages and overall process. What is the De Novo Process? When this process is used? Overview of the process Advantages of De Novo Process Cost The cost to purchase the video recording is $395. Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.

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