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The MSBA's Food Drug & Device Law Section in collaboration with LifeScience Alley Presents


FDA's Guidance: New Medical Device Premarket Processes

The MSBA Food Drug & Device Law Section is proud to co-host this meeting with LifeScience Alley.

In the past several months, CDRH has issued more new guidances and SOPs than at any time in modern memory. These guidances address issues of critical importance to the device industry and cut across all product types. Experienced regulatory professionals are scrambling to keep abreast of these new requirements and are struggling to understand the details and implications of them all.

Topics include:
• New clinical trial guidances
• Access to experts and CSC
• New 510(k) paradigm
• Washington Update Modifications
• Risk Benefit
• De novo and HDE
• Special products and situations - Mobile medical Apps, MDDS, etc
• 522 orders and post market
• Appeals


Mark DuVal, J.D., President, DuVal & Associates, P.A.

Mark Gardner, MBA, JD, Attorney, DuVal & Associates, P.A.

Ralph F. Hall, JD, Professor, University of Minnesota - Law School

Robert Klepinski, Officer, Fredrikson & Byron, P.A.

Christopher Pulling, MS, Partner, The Integra Group

Ann Quinlan-Smith, RAC, President, Alquest, LLC

Paul Sobotka, M.D., Entrepreneur In Residence, Food and Drug Administration, United States Department of Health and Human Services

Vincent J. Ventimiglia, Jr., JD, Sr. Vice President, Faegre Baker Daniels LLP;

6.75 hours of Standard CLE credits have been applied for. The event code is 165607.



Date: Thursday, March 29, 2012

Time: Registration: 8:00 am - 8:30 am
Program: 8:30 am - 4:30 pm

Location: Crowne Plaza Minneapolis North
2200 Freeway Blvd., Minneapolis, MN 55430

Cost: $375.00 if registration is received by Thursday, March 22
$425.00 if registration is received after March 22.

How To Register:The MSBA is not handling registration for this program. Food Drug & Device Law Section members should register directly with LifeScience Alley at this link.