Sponsored by Drexel University Center for Graduate Studies

Recent and Pending Changes to the FDA and the 510(k) Process

When:

Wednesday, October 26, 2011

Time:

8:30 am - 11:30 am
Registration, breakfast and networking from 8:30-9:00 a.m.

Location:

Drexel University, One Capitol Mall, Suite 260, Sacramento, CA 95814

Course Description:

In January, The Food & Drug Administration announced that it planned to make 25 changes to its 510(k) medical device clearance program in 2011. Some of those changes have been implemented; many are still pending. In addition, the Institute of Medicine(IOM) report issued in July shocked the regulatory community with it’s recommendation to scrap the 510(K) process entirely. In this survey course, we will review the current state of FDA changes and what to expect in the months ahead. This will be practical advice for entrepreneurs actively working to bring a device to market.

Points to be covered:

• Institute of Medicine (IOM) Recommendations-- is the FDA likely to Scrap the 510(K) process?
• Center for Devices & Radiological Health’s (CDHR) progress on 25 point Action Plan -- What has changed in 2011? What is likely to change in the near future?
• New FDA Guidance documents -- where to find them, and how they can guide product planning
• Understand the issues with industry innovation and the 510(k) process
• Given this climate of pending change, how do I move forward on the approval process for my device?

Presenters:

Consuelo Hernandez, VP State Government Affairs, CHI-California Healthcare Institute

Maureen Mende, RAC, MBA, Senior Director, Myraqa, Inc.

Lorry Huffman, MT(ASCP), CLS, Senior Director, Myraqa, Inc.

Myraqa, Inc. - headquarted in Redwood City, CA Myraqa is a boutique regulatory consulting firm focused exclusively on in vitro diagnostics (IVDs). Myraqa works with clients throughout the US and EU, who specialize in IVD and pharmaceutical manufacturing, CLIA labs, and other industry stakeholders.

Cost:

General Admission: $40; SARTA Members: $25

Price includes free parking for 4 hours at the One Capitol Mall Valet Garage on 2nd Street (valued at $8) and a continental breakfast.

If you are a SARTA member, please email members@sarta.org for member discount code.

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Presenter Bios:

Consuelo Hernandez, VP State Government Affairs, CHI-California Healthcare Institute
Consuelo Hernandez joined CHI as the vice president of state government affairs in December 2010. In that capacity, she is responsible for managing CHI's Sacramento office where she directs the organization's state government relations advocacy and outreach activities across issues including state budget and taxes, education and workforce development, environmental regulation and healthcare reform implementation.

Prior to CHI, Consuelo held a number of positions including director of the Assembly Fellowship Program for CSUS, director of government affairs for L.A. Care Health Plan, legislative consultant for Sen. Ortiz (D-Sacramento),  attorney with Sonnenschein Nath & Rosenthal and attorney with Baker & Hostetler.

Consuelo received her undergraduate degree in human development from the University of California at Davis. She received her law degree from Stanford Law School. She is admitted to practice law in California.

Maureen Mende, RAC, MBA, Senior Director, Myraqa, Inc.

Maureen has spent the last 25 years working in the healthcare industry specifically in the areas of regulatory and quality. For the past two years she has been working for Myraqa helping clients navigate through the regulatory and quality aspects of IVD product development. Prior to joining Myraqa Maureen spent two years at Affymetrix, as Director of Regulatory Affairs and prior to that spent 15 years at Dade Behring where she was responsible for the regulatory affairs group for the Microbiology product line. Maureen also spent a year with a small start up company, called Diamics and spent several years in the Quality Assurance group of the Consumer Products Division of Abbott Laboratories. Maureen has played leadership and execution roles in the regulatory approval/clearance for IVD projects, product development, quality system development, clinical trials and post-market compliance. In addition to obtaining numerous FDA approvals and clearances, she has had IVD product approvals in Canada, EU, China and Japan.

Lorry Huffman, MT(ASCP), CLS, Senior Director, Myraqa, Inc.

Lorry Huffman - Lorry joined Myraqa in July 2010 making a move from Volcano Corporation’s Senior Director of Regulatory Affairs. She has a greater than 20 year history in the Medical Device and Pharmaceutical Industries working in the areas of Regulatory Affairs and Quality Assurance with companies such as Baxter Healthcare Corporation and ALZA Corporation which is now a J&J Company. She was a Regulatory and Quality Consultant for several years for companies such as Genentech, Medtronic AVE, and Thermogenesis. Her expertise is in global regulatory and quality issues including US, EU, Japan, Latin America, and Asia Pacific. She is a state and nationally licensed Clinical Laboratory Scientist (MT-ASCP; CLS-NCA) and has worked in both hospital and reference laboratories.

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About SARTA's Leadership Series Med Tech Track
SARTA is committed to engaging members and the regional tech community in quality educational programming. The quarterly Med Tech Track series of seminars are focused on providing medical technology executives with immediate tools for business growth. Each session is approximately 3 hours in length and is held at our partner locations across the region. SARTA recruits speakers and panelists from the private sector who have many years of expertise in subject of each seminar.

Drexel University sponsors the Leadership Series because the eleven doctoral and master’s programs it offers at its new Center for Graduate Studies in Sacramento are designed to advance the development of the region’s next generation of leaders, and for the working professional who sees the coming opportunities to step up in their careers.