Clear as Mud: Obtaining & Marketing your 510(K) with Today's FDA
President, DuVal & Associates, P.A
Associate Attorney, DuVal & Associates, P.A
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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.
An update on what is happening politically with FDA and Congress on the 510(k) program.
- This will include an update on the activities of FDA's internal working groups, the Institute of Medicine's report on the 510(k) program and the advocacy of AdvaMed , MMDA, LifeScience Alley and the Minnesota Medical Device Alliance co-founded by the DuVal law firm;
A brief review of the statute, regulations and guidance documents that are the underpinnings of the 510(k) program; along with insights on the direction CDRH is headed today with the 510(k) program;
An examination of common mistakes seen in drafting and prosecuting 510(k)s through the regulatory process-how to make the best submission possible the first time through, including:
- Understanding that today's 510(k) is no longer a cut and paste boilerplate document, it is an advocacy document from submission to clearance that requires strategic and tactical implementation;
- Choosing the right predicate, the use of multiple predicates, split predicates and when to argue "technological precedent;"
- Understanding the intricacies behind "substantial equivalence" including the "same intended use" statement?when it is modified by the submission content and how new and multiple uses come into play;
- Examining the criterion of "same technological characteristics" and how to position it with CDRH;
- A review of what belongs in a submission and what doesn't;
- An honest look at when data, especially clinical data, will be needed; when to meet with FDA and thoughts on filing IDEs;
- A discussion of when a de novo becomes an attractive option and how to go about it; and
- A primer on your relationship with the reviewer, Branch Chief and Division Director.
What to do when things don't go right
- Answering Additional Information (AI) letters
- The use of outside experts
- When and how to push back
- Meeting with FDA and who to take and how to prepare
- The appellate process at CDRH,
- What avenues to pursue and when, including the use of the Office of the Ombudsman.
When you get your 510(k) what do you do with it?-marketing your 510(k) including:
- Beginning with the end in mind-providing marketing, clinical and reimbursement input before a 510(k) is submitted to explore what claims will make the product differentiable in the marketplace vs. the constraints found in the labeling of your chosen predicates vs. the level of substantiation required vs. the impact on reimbursement coding, coverage and payment;
- A deep dive on your labeling-what is on- or off-label, a review of CDRH's General vs. Specific Use Guidance document and the position of today's CDRH;
- What can you do to promote your general intended use and how to deal with specific indications-the three "buckets" of promotion, communication and dissemination;
- A primer on communication strategies in press releases, websites, Notices of Availability (NOAs), providing grants for CME and physician-initiated trials, market research, speaker's bureaus, social media and the like; and
- What to do when FDA disagrees with your promotional positioning-including a brief update on enforcement
President, DuVal & Associates, P.A
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.
Associate Attorney, DuVal & Associates, P.A
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
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- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
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I found the training very helpful. Personal experience in communicating with FDA and details like “bring your own projector” were much appreciated.
- RA Manager, Terumo Medical
The seminar was very interesting and informative.
|- RA Specialist, B. Braun Medical, Inc
Speakers were very good and knowledgeable. examples were good and we could relate to them.
|- RA / validation Manager, IrvineScience