Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop

Course Description:

Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn.

Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH’s new proposals for the 510(k) program. He will also discuss the plusses and minuses of pre-IDE meetings and how to approach them.

Mr. DuVal will address when and how to appeal adverse 510(k) decisions, whether it be an NSE decision or an Additional Information letter, learned in the trenches with FDA. This will include a workshop in which participants will be given hypotheticals to work on in small groups and share with the entire group the position they would take in an FDA appeal meeting.

On day two Mr. DuVal will spend a half day focusing on the promotional side of marketing a 510(k) starting with the analysis of how to take to market with a general intended use statement and specific uses (indications) to which the device may be put. He will cover FDA’s “General/Specific Intended Use” Guidance document and discuss how FDA approaches the interpretation of it using real examples. He will also share ideas for e-clearance/pre-approval communications, as well as the promotional issues companies face post-approval, including FDA’s enforcement activities with respect to the promotion of general versus specific uses. This will also include a workshop where the participants will again work in small groups to construct a promotional plan for a fictional medical device.

Please join us at this interactive 510(k) Workshop that will tackle the following questions:

510(k) PROSECUTION

• How do you obtain a 510(k) in today's environment at FDA? How to position your 510(k) submission. How you fashion the intended use statement to convince FDA that the new indication is not a new intended use?  How to argue the technological characteristics are the same and do not raise ''new types'' of questions of safety and effectiveness. How to use the new concept of ''reference'' devices in your submission.
• How do you address the sufficiency of your performance data and respond to requests for animal or clinical data (feasibility and pivotal)? Do you have pre-IDE meetings or not? Do you offer clinical data in your initial submission or not?
• What role does the Least Burdensome Guidance regulation and guidance documents play and how to raise them with FDA?
• How to answer Additional Information (AI) letters and when and how to push back at meetings with FDA. When do you escalate matters and how? Who do you involve, when and why?
• What to do when things do not go right; how to prepare the appellate process at CDRH.  When and how to appeal; who to take and how to prepare?
• What avenues to pursue for appeal/persuasion? When, if at all, do you consult/involve the Ombudsman, the Office of Chief Counsel?

MARKETING A 510(k) DEVICE

• Once you get your 510(k), how can you market a product with a general intended use statement when your product can be used in many indications (uses/patient populations)?
  • Developing your promotional plan with a general intended use statement
  • Understanding FDA's hot buttons, enforcement and how to avoid trouble
  • Making appropriate risk-based decisions, i.e. how to be appropriately aggressive, yet complaint
  • Guiding your management through the process
• How communication strategies can differ pre-clearance versus post-clearance.
• What to do when FDA disagrees with your promotional positioning.
• Workshop on developing a promotional/regulatory plan.

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

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