“Benchmarking New Requirements of the FDA Safety and Innovation Act”

A Webinar Series for the Medical Device Industry

Skip to: Schedule, Pricing, Speakers

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

Watch our website for a detailed agenda and updates in November!

Webinar Schedule

December 12, 2012: 1:00 - 2:30 PM EST

• 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

June 2013, TBA

• 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

December 2013, TBA

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

Webinar Pricing

Register for all 3 webinars and receive a 10% Discount!

Notices:

• * A Small business is one that has <100 employees.
• ** A consultant is an individual from companies of less than 10 employees.
• ***A start-up company is one that manufactures product. A start-up company who provides only services is not included in this category. The start-up company must not have product on the market yet, and therefore no revenue being generated. The Start-up Company has <10 employees 

Speakers 

Steven Niedelman
Lead Quality System & Compliance Consultant. King & Spalding

Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.

Prof. James O’Reilly, J.D. Professor
University of Cincinnati College of Law

Professor O’Reilly has been involved with FDA issues since 1974. He authored the standard reference encyclopedia on FDA for westgroup.com, which the U.S. Supreme Court quoted with the words, “The experts have written…”. He chairs the FDA committee of the American Bar Assn., is on the editorial board of the Food & Drug Law Journal, formerly chaired the programs committee of the Food & Drug Law Institute, and was keynote speaker at the FDA’s midwest celebration of its 100th anniversary in 2006. Before his academic career, he was principal FDA legal adviser for Procter & Gamble, and is the last active member of the team that negotiated the terms of the 1976 medical device amendments. He has published 45 texts and 180 articles since 1977.