Course Description:

The FDA has attempted to refine the 510(k) program in some subtle and not-so-subtle ways—the sum total of which has redefined the program, making the agency’s clearance of a 510(k) more unpredictable for device companies and their investors. The existing 510(k) program and the complex clearance process can lead to companies unnecessarily spending millions of dollars.

This one-and-a-half day seminar aims to help device companies and professionals understand the 510(k) clearance process and learn the best practices in obtaining clearance quickly with minimal wastage of resources. The seminar instructor, Mark DuVal, is a leading authority on FDA regulations and specifically the 510(k) program. Mr. DuVal recently filed a Citizen Petition on behalf of the Minnesota Medical Device Alliance (MMDA), asking the FDA to hold off finalizing guidance on evaluating substantial equivalence for 510(k) devices until the agency addresses a laundry list of regulatory issues identified by the alliance.

Day one of the seminar will provide insights into what FDA looks for in a 510(k) submission and common mistakes companies make in drafting 510(k)s.

  • Insights and commentary on CDRH’s new proposals for the 510(k) program
  • Discussion on the pluses and minuses of pre-IDE meetings and how to approach them
  • When and how to appeal adverse 510(k) decisions, whether it is an NSE decision or an Additional Information letter.

A practical workshop will be conducted in which participants will be given hypotheticals to work on and share their opinion on what position they would take in an FDA appeal meeting.  This seminar will also explain what to expect when FDA proposes the de novo path.

Day two of the seminar will focus on the promotional side of marketing a 510(k) device.

  • It will review FDA’s “General/Specific Intended Use” guidance document and discuss how FDA approaches the interpretation of it using real examples
  • Mr. DuVal will also share ideas for pre-clearance/pre-approval communications.
  • He will also discuss the promotional issues companies face post-approval, including FDA’s enforcement activities with respect to the promotion of general versus specific uses.

A practical workshop will be conducted where the participants will gain knowledge on how to construct a promotional plan for a fictional medical device.

Who will Benefit:

This seminar on 510(k) medical device will be beneficial for the following regulatory personnel in medical device companies:

  • CEOs &CFOs in medical device companies
  • VPs, Directors and Heads of Regulatory Affairs
  • VPs, Directors and Heads of Clinical Affairs
  • Senior and line Marketing and Sales Management
  • Regulatory Consultants
  • Attorneys
  • Risk Managers
  • Engineering & R&D
  • Professionals involved with premarket notification to the FDA
  • R&D personnel involved in approving the design of medical devices
  • Medical device sales and marketing personnel

Topic Background:

Mr. DuVal, on January 2, 2013, filed a Citizen Petition on behalf of the Minnesota Medical Device Alliance (MMDA), an unincorporated, voluntary affiliation of pre-revenue, small and mid-tier medical device companies, venture capitalists and some inventing physicians. This joint petition is being filed on behalf of the medical device industry generally to challenge and force discontinuation of the administrative practices and definitional interpretations that FDA has put into practice since 2009 in reviewing 510(k)s which have dramatically changed the manner in which the 510(k) program operates. Among the requested actions, Mr. DuVal’s petition requests that the Commissioner stay the implementation of the following guidance document, “Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” dated December 27, 2011, (hereinafter “the New 510(k) Guidance”) and to revert to use of the 510(k) guidance documents currently in existence, until FDA has had the time to obtain additional, more meaningful input from industry.

Areas Covered:

This interactive 510(k) workshop will help to deal with the following:

  • Obtaining a 510(k) license in today's environment from the FDA
    • 510(k) submission
    • Design the intended use statement to convince the FDA that the new indication is not a new intended use
    • Argue the technological characteristics are the same and do not raise ''new types'' of questions of safety and effectiveness
  • Address the sufficiency of your performance data and respond to requests for animal or clinical data
  • Role of the Least Burdensome Guidance regulation and guidance documents and how to raise them with FDA?
  • Prepare the appellate process at CDRH
  • What avenues to pursue for appeal/persuasion?
  • Actions to taken when the FDA proposes or pushes you onto the de novo path
  • Marketing a FDA 510(k) device with a general intended use statement when your product can be used in many indications (uses/patient populations)
    • Understanding FDA's hot buttons, enforcement and how to avoid trouble
    • Developing your promotional plan with a general intended use statement
    • pre-clearance versus post-clearance communication strategies
    • Making appropriate risk-based decisions, i.e. how to be appropriately aggressive, yet compliant

Course Outline:

Day 1: 510(k) PROSECUTION:     Day 2: MARKETING A 510(k) DEVICE:
  • 8:30-9:00 am :- Registration and breakfast
  • 9:00 am :- Session Start
  • 9:00-10:45:- Introduction to program; political background for the 510(k) program
  • 10:45-11:00:- Coffee Break
  • 11:00-12:30:- A review of the statute, regulations and new and old guidance documents that are the underpin the 510(k) program; along with insights on the direction CDRH is headed today with the 510(k) program
  • 12:30-1:30:- Lunch
  • 1:30-3:00 :- How to draft your 510(k) submission as an advocacy document; Common mistakes; knowing what FDA is looking for in the submission
  • 3:00-3:15:- Break
  • 3:15-4:15 :- What to do when things do not go right; Appealing FDA decisions
  • 4:15-5:30:- Workshop on 510(k) appeals
  • 8:30-9:00:- Breakfast
  • 9:00-10:00:- Understanding how to apply FDA’s General/Specific Intended Use Guidance document
  • 10:00-11:15:- Understanding pre-clearance and post-clearance communication and marketing opportunities
  • 11:15-11:30:- Break
  • 11:30-1:00:- Workshop on developing a promotional/regulatory plan

Meet Your Instructor

Mark DuVal
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.

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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.

Mark was preferred speaker for seminar. His experience as a lawyer representing Phrama/Device companies and his experience with FDA brings good examples to the sessions.
- Manager, Clinical Affairs, PharMEDium Services, LLC.

It was a good learning with Mark that common mistakes seen in drafting and prosecuting 510(k)'s; And what do when things go wrong. Understand how the FDA functions.
- Regulatory Affairs Specialist, CooperVision.

I really liked the seminar. Mark is very practicle. He had some great "nuggets" and better data.
- Regulatory Project Manager, NAMSA.

Mark is very knowledge. I enjoyed the session on legal cases.
- Sr. Regulatory Affairs Specialist, CooperVision.

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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