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In the popular television series Survivor, individuals are placed on an island isolated from reality with odds stacked against them, fighting for their survival while the rulers of the island constantly change the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor. Unlike Survivor – there is plenty of room for more than one winner.
Most medical devices come to the US market through the 510(k) program. Although the regulatory criteria have not changed, FDA has significantly reshaped (expanded) its expectations over the years, leading to ever-increasing complexity in 510(k) submissions. This makes it much more difficult to obtain a positive clearance decision, particularly for today’s innovative products.
In this two-day, in-person workshop, regulatory experts will review the current requirements and expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program, providing you with the tools to be a survivor of this ever-changing program.
Upon completion of this workshop, participants should be able to:
Monday, June 27, 2022
Day 1: 510(k) Deeper Dive
Tuesday, June 28, 2022
510(k) Managing Interactions w. FDA and Post-clearance activities
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 with the FDA in relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. He works extensively with FDA on 510(k)s, de novos, PMAs and combination products, IDE negotiations, pre-submissions, inspections, warning letters, appeals, etc.
Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A. She works extensively on worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, de novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications; quality system strategies, SOP development and review, and compliance topics.
Allison Komiyama is a regulatory consultant focused on FDA submissions for the medical device industry. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of device companies. Her company (AcKnowledge Regulatory Strategies, LLC) was purchased by RQM+ in late 2021.
Registration fee includes:
Early Bird 31 May 2022
Regular by 21June 2022
Drury Plaza Hotel St. Paul Downtown
175 10th Street E.
St. Paul, Minnesota 55101
A limited number of rooms is available at the rate of $135.00 + tax.
Book online at www.druryhotels.com or by phone: + 1 800 325 0720
Group Code: 2451470
Reservations must be made no later than 31 May 2022.
RAPS will require proof of COVID-19 vaccination for all participants attending RAPS in-person workshops & programs. Your well-being is RAPS’ #1 priority.
Unvaccinated individuals or those unable to provide proof of vaccination in advance will not be permitted to attend.
RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. Cancellation requests received by Friday, 27 May 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 27 May 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org