Clear as Mud: Obtaining & Marketing your 510(K) with Today's FDA

(www.complianceonline.com)

Course Description:

An interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA.

Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal, a national authority on the 510(k) program is in Silver Spring, Md. at FDA nearly twice a month negotiating 510(k) issues for his clients. Mr. DuVal will teach you the tips and tricks of the trade that he has learned in the trenches with FDA. Both attorneys also participate in the national dialogue on the proposed changes to the 510(k) program. Mr. Gardner will focus on pre-clearance/pre-approval communication, as well as the promotional issues companies face once they are on the market.

Practical questions answered at the workshop:
How do you obtain a 510(k) in today's environment at FDA? How do you position your 510(k) submission? How do you fashion the intended use statement and argue the technological characteristics are the same and do not raise "new types" of questions of safety and effectiveness?
What to do when things do not go right? How do you answer Additional Information (AI) letters, when and how to push back meetings with FDA, whom to include and how to prepare the appellate process at CDRH, what avenues to pursue and when?
When you get your 510(k), how do you market a product with a general intended use statement when your product can be used in many specific indications/patient populations? What communication and dissemination strategies should you adopt? What to do when FDA disagrees with your promotional positioning?
A proper understanding of the 510(k) process from start to finish is critical to avoid problems. In addition, an understanding of FDA-compliant promotional strategies is very essential for you and your company to succeed in this complex regulatory environment.

Who will benefit?

CEOs
VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
Regulatory affairs
Attorneys
Quality Assurance
Risk Managers
Risk Management team members
Quality Engineering
Market Research
Clinical
MDR Reporters
Production
Engineering & R&D
Professionals involved with premarket notification to the FDA
R&D personnel involved in approving the design of medical devices
Sales personnel involved in approving the marketing of medical devices

Meet Your Instructor

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance (federal and state anti-fraud and abuse laws, anti-kickback analysis, HIPAA & HITECH, and development of training and compliance programs) and promotion (appropriate and lawful off-label dissemination procedures, sales contracts, labeling and advertising review, continuing medical education programs (CME), product launch campaigns, pre-approval communications programs, direct-to-consumer (DTC) advertising, and domestic and international web strategy). Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and previously in sales roles. While working at ev3, Celleration, and Medtox Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.