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.
To Register for this seminar, please follow this link: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80001SEM