ACQUIRING KNOWLEDGE OF COMBINATION PRODUCTS, DESIGNATION REQUESTS, AND PRODUCT JURISDICTION

This webinar will provide an in-depth discussion on understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (rfd), and how to work with the Food and Drug Administration (FDA) when submitting applications for combination products. In order to do this, it will make use of the comprehensive information that is provided by the office of combination products at the FDA. Why should you bother to come? You should go if you want to avoid making costly and time-consuming mistakes when determining which division of the FDA will have primary jurisdiction over a particular combination product. This can be avoided by having a solid understanding of the process by which the FDA reviews combination products. Companies will be able to have the most relevant information in their submissions and know who their primary contacts will be within the Food and Drug Administration (FDA) if they have an understanding of how the FDA decides which center will be the lead center for the review of an application for a combination product (i.e., which center will be the lead center for review of the application). areas such as these were discussed throughout the session: An explanation of what a combination product is and some examples of categories for combination items the evaluation process for combo goods instructions on how to put together a request for designation (rfd) a guide to working with the Food and Drug Administration when filing applications for combination goods who will come out on top: professionals working in regulatory matters personnel tasked with the obligation of conducting preclinical tests on medical equipment any firms in the United States that are in the process of developing, producing, and selling medical devices should contact: http://www.globalcompliancepanel.com globalcompliancepanel usa phone:800-447-9407 fax: 302-288-6884 webinars@globalcompliancepanel.com

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