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

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

• 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