Survivor: The FDA 510(k) Program Edition

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:

• Understand how to select an appropriate predicate device
• Prepare a 510(k) submission that appropriately advocates for its clearance
• Understand how to use available tools to get a submission-review process back on track
• Know how to properly maintain a cleared 510(k)
• Enjoy the free chocolate provided at the end (must be in attendance to enjoy)

Program Agenda:

Monday, June 27, 2022

510(k) Basics

• 9:00-9:30am: 510(k) Survivor Initiation
• 9:30-10:15am: History of the 510(k) - Its origins, its purpose, its shortcomings, Structure of the 510(k), timeline/MDUFA metrics, relevant FDA guidance, types of 510(k)s
• 10:15-10:30am: BREAK
• 10:30 – 12:00pm: Presenting and supporting the definitional elements of the 510(k) program (Intended Use vs Indications for Use, technological characteristics and questions of safety and effectiveness, evaluation of potential predicate devices, and submission advocacy)
• 12-1:30pm: LUNCH

Day 1: 510(k) Deeper Dive

• 1:30-2 pm: Regulatory strategy, finding/understanding device-specific guidance, determining the testing needed to support your 510(k)
• 2-2:45 pm: Deeper dive into various sections of the 510(k)
• Executive Summary
• Forms 
• Device Description
• Substantial Equivalence (SE) Section
• 2:45-3 pm: BREAK
• 3-4 pm: Deeper dive into various sections of the 510(k)
• Performance testing - Bench, Animal Testing, Clinical
• Labeling
• Software, Cybersecurity, EMC/ES
• 4:00 – 4:30 pm: Administrative Aspects of Submission
• Refuse to Accept (RTA) Checklist
• eCopy Requirements
• User Fee Requirements
• Small Business Designation
• Use of optional eSTAR program
• 4:30 – 5:00 pm: Q&A

Tuesday, June 28, 2022

510(k) Managing Interactions w. FDA and Post-clearance activities

• 9-10:30 am: FDA interactions and best practices
• Use of Pre-Sub program
• RTA holds/eCopy holds/User Fee holds
• Additional Information (AI) requests / Telephone holds and understanding 4-Part harmony
• 10-Day teleconference call
• Submission Issue Requests (SIRs)
• 10:30 – 10:45 am: BREAK
• 10:45 – 12:00 pm: Getting the review process back on track
• Least Burdensome (LB) Flags
• Appeals
• Ombudsman interactions
• 12:00 - 1:30 pm: LUNCH
• 1:30 - 2:30 pm: Post-clearance 
• Modifications Assessments
• Letter-to-File strategies
• What does a ‘catch up’ 510(k) look like
• Considerations for a 1^st product clearance (Registration & Listing, QMS)
• 2:30 – 2:45 BREAK
• 2:45 – 4:00: 510(k) Survivors Panel Discussion
• 4:00 – 4:30 pm: Summary
• 4:30 – 5:00 pm: Q&A / Wrap up meeting and unwrap the chocolate

June 28, 2022 12:00 pm – 1:30 pm Conversations that Matter: Ask the Experts (boxed lunch provided)

Workshop Facilitators:

Mark DuVal, JD, 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 the US Food and Drug Administration (FDA) on 510(k)s, de novos, PMAs and combination products, IDE negotiations, pre-submissions, inspections, warning letters, appeals and more.

Lisa Pritchard, BSEEE, is VP of regulatory, quality, clinical and engineering at DuVal & Associates, P.A. She works extensively on worldwide regulatory strategies, marketing submissions and applications including 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, Australian listing applications, quality system strategies, SOP development and review and compliance topics.

Allison Komiyama is a regulatory consultant focused on US Food and Drug Administration (FDA) submissions for the medical device industry. She received her PhD 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.

Ken Skodacek, FDA Ombudsman

Dongbo Wang, Ph.D. is Senior Director of Regulatory at Galvanize Therapeutics, a Bay Area start-up company creating non-thermal pulsed electric field based devices for pulmonary and cardiac indications, regulated through both 510(k) and PMA pathways. Prior to joining Galvanize, he worked in the US Food and Drug Administration (FDA)’s Center for Drug Evaluation (CDER) and Office of Product Evaluation and Quality (OPEQ) regulating dental, general surgical and respiratory devices. Throughout his FDA career he primarily reviewed CDRH premarket submissions. He is very much enjoying the transition to industry and collaborating to create innovative medical devices.

Carrie Powers, President and CEO, Reprise Biomedical, Inc.

Steve Anderson, CEO, Preceptis Medical

Pricing Amounts & Deadlines

Registration fee includes:

• Breakfast and lunch each day
• Continuous beverage break service
• Complimentary evening Drury Kickback® of hot food, soft drinks, beer, wine, & mixed drinks
• Complimentary Wi-Fi
• Complimentary parking

Location

Drury Plaza Hotel St. Paul Downtown
175 10th Street E.
St. Paul, Minnesota 55101

Reservations:

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.

Vaccination Requirement

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.

Cancellations and Refunds

All cancellation requests must be submitted in writing to support@raps.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.

Substitutions

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 support@raps.org 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.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org