Obtaining Faster FDA 510(k) Clearance - The 510(k) as an Advocacy Document
Mark DuVal, J.D, President of DuVal & Associates
Coming soon.. Please contact customer care for new schedule
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
- 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
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.
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
|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
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.
Register by P.O. / Check
Yes, I want to attend "Obtaining Faster FDA 510(k) Clearance - The 510(k) as an Advocacy Document".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
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
If you wish to partner with us for this event
contact us: email@example.com
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media Partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner to do
- Banner (min 728x90 or 468x60) on the Media Partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the Magazine and/or Website.
- Dedicated email blast to all subscribers of Media Partner.
- Article on the Magazine and/or Website after the conference.
If you wish to sponsor this event
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
Morehead Planetarium and Science Center:
Morehead Planetarium and Science Center is one of the oldest and largest planetariums in the United States. Morehead Planetarium and Science Center offers an informal learning environment for science education that serves nearly 170,000 visitors every year. Its programs include summer science camps, science cafes, family science activities and statewide outreach, featuring the DESTINY mobile science lab and PLANETS portable planetarium.
Museum of Life and Science:
The Museum of Life and Science is one of North Carolina’s top attractions. Situated on 84-acres, the interactive science park includes a science center, a butterfly conservatory which is one of the largest in the world and beautifully-landscaped outdoor exhibits which are safe havens for rescued black bears, lemurs, and endangered red wolves. The Museum's Dinosaur Trail takes visitors on a journey through the Late Cretaceous period.
West Point on the Eno:
Located along a two mile stretch on the scenic Eno River, this 388 acre city park offers a variety of recreational activities such as picnicking, hiking, canoeing, and rafting. An amphitheater is also inside the park, as well as many historic buildings such as a reconstructed 1778 working gristmill, the McCown-Mangum House built in the 1880s, the Hugh Manhum Museum of Photography, and a recreation of a 19th century blacksmith shop.
Sarah P. Duke Gardens:
Duke Gardens is recognized as one of the premier public gardens in the United States, renowned for its landscape design and high quality horticulture. Each year, more than 300,000 visitors come to Duke Gardens from all over the world. Of special interest is their 20-acre Culberson Asiatic Arboretum. About 550 species and cultivars of Asian plants present a living example of the close relationship between the flora of the Eastern U.S. and the flora of eastern Asia.
One of the largest pre-Civil War plantations, this historic plantation offers visitors a glimpse into the past, particularly of the African American slaves who worked the plantation. Two beautifully restored historic buildings and an old barn are on site and self guided tours of the extensive grounds are available, as well as an array of learning opportunities.
St. Joseph's AME Church:
One of the first autonomous African-American churches in America, this beautiful church was converted into a performance hall in 2001 and features an 1891 brick sanctuary that includes a stained glass portrait of Washington Duke.
Duke Homestead State Historic Site:
This historic site includes authentic tobacco barns and original factories, as well as a museum filled with cigarette manufacturing and marketing memorabilia. Living history demonstrations of life on a typical yeoman farm in the 1800's are regularly performed.
Duke University Chapel:
Durham's most popular tourist attraction, the Duke University Chapel (built in 1930) is a prime example of English-Gothic architecture and represents one of the last great collegiate Gothic projects in the United States.