Event Details

 The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?

This webinar series will occur semi-annually, allowing you to benchmark where you and your company stand as the provisions of FDASIA go into effect over 2013. The webinars will provide details of the new law that directly impact the Medical Device Industry from experts and the FDA. Use the FDASIA benchmarking webinar series to evaluate your company’s compliance to the new FDA expectations and requirements. Our experts will provide company leaders with the tools to stay on course for compliance as the FDA’s expectations evolve over 2013.

Some of the provisions that will be discussed are:

• New 510(k) requirements
• The Unique Device Identifier system
• Changes to industry participation in guidance development
• Keeping up with User Fees

The December 12, 2012 1:00 - 2:30 PM EST webinar will include:

• Steve Niedelman, Former FDA Deputy Associate Commissioner, Lead Quality System & Compliance Consultant, King and Spalding
• Jim O’Reilly, JD, Professor, University of Cincinnati
• FDA Headquarters, TBA

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