ComplianceOnline

Course Description:

Course "Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop" has been pre-approved by RAPS as eligible for up to 10.5 credits towards a participant's RAC recertification upon full completion.

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



Course Outline:

DAY ONE

DAY TWO

  • 8:00-8:30:- Registration and breakfast
  • 8:30-10:15:- Introduction to program; political background for the 510(k) program
  • 10:15-10:30:- Coffee Break
  • 10:30-12:00:- 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
  • 12:00-1:00:- Lunch
  • 1:00-2:30 :- How to draft your 510(k) submission as an advocacy document; Common mistakes; knowing what FDA is looking for in the submission
  • 2:30-2:45:- Break
  • 2:45-3:45 :- What to do when things do not go right; Appealing FDA decisions
  • 3:45-5:00:- Workshop on 510(k) appeals
  • 8:00-8:30:- Breakfast
  • 8:30-9:30:- Understanding how to apply FDA’s General/Specific Intended Use Guidance document
  • 9:30-10:45:- Understanding pre-clearance and post-clearance communication and marketing opportunities
  • 10:45-11:00:- Break
  • 11:15-12:30:- 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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Testimonial

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.



Accreditation




The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.



After completion of course "Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop" RAPS certificate will be issued to attendee.





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