Understanding Combination Products, Requests for Designation and Product Jurisdiction

MessageThis Webinar is over
Date Aug 14, 2014
Time 12:00 PM EDT
Cost $225.00
This webinar will provide a detailed discussion of 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 FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA's Office of Combination Products. 

Why Should you Attend: You should attend because understanding how combination products are reviewed by FDA is critical to avoiding costly and time-consuming mistakes with respect to which part of FDA will have the primary jurisdiction for a given combination product. Understanding how FDA determines the primary jurisdiction for a combination product (i.e., which Center will be the lead Center for review of the application) will allow companies to have the most appropriate information in the submission and know who their primary contacts in FDA will be. 

Areas Covered in the Session:
  • Definition of a combination product
  • Categories of combination products
  • How combination products are reviewed
  • How to assemble a request for designation (RFD)
  • How to work with FDA when submitting applications for combination products

Who Will Benefit:
  • Regulatory Affairs Professionals
  • Staff with responsibility for preclinical testing of medical devices
  • All companies developing
  • Manufacturing and Marketing medical devices in the US
Quick Contact:

USA Phone:800-447-9407
Fax: 302-288-6884


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