Survivor: The FDA 510(k) Program Edition (April 2023)

RAC Credits
Thursday, 20 April 2023 (9:00 AM) - Friday, 21 April 2023 (4:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

In the popular television series “Survivor,” contestants are left on an isolated island with the odds stacked against them; they fight for survival amid constantly changing rules. 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 with little chance of being “the survivor.” Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to survive on the show. Unlike TV—there is plenty of room for more than one to survivor!

Most medical devices come to the American market through the 510(k) program. Although the regulations haven’t changed, the FDA has reshaped and expanded its expectations, leading to ever-increasing complexity in submitting 510(k) applications. In this two-day, in-person workshop, regulatory experts will review the program’s requirements and expectations, provide strategies to help ensure success with program submissions, and arm you with the tools to be a “survivor.”


January 6, 2023 — March 20, 2023: Early Bird $1,135.00 Member | $1,340.00 Nonmember

March 21, 2023 — April 20, 2023: Regular $1,340.00 Member | $1,570.00 Nonmember

Learning Objectives

Upon completion of this workshop, participants should be able to:

  • Select an appropriate predicate device
  • Prepare a 510(k) submission that appropriately advocates for its clearance
  • Get a submission review back on track
  • Maintain a cleared 510(k)
  • Enjoy the free chocolate provided at the end (must be in attendance to enjoy)

  • Who Should Attend?

    Regulatory Affairs Professionals.


    April 20, 2023

  • Program history
  • Program structure and FDA guidance
  • Presenting and supporting the program’s definitional elements
  • Intended Use vs. Indications for Use
  • Technological characteristics and questions of safety and effectiveness
  • Evaluation of potential predicate devices
  • Submission advocacy
  • Regulatory strategy
  • Deep dive into program content expectations
  • Administrative aspects of program submissions

  • April 21, 2023

  • FDA interactions and best practices
  • Options for getting a review back on track
  • Post-clearance activities
  • Program “survivors” panel discussion
  • Summary & wrap-up

  • Instructors:

    Mark DuVal, J.D.

    Mark DuVal, J.D.

    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 provides strategic regulatory advice, develops compliance programs, designs and implements sophisticated marketing programs, counsels on reimbursement matters, conducts sales training, teaches interfacing with the FDA in relation to product approval and clearance, and advises on clinical trial negotiations, approvals, policy arguments, and appeals. He works extensively with the FDA on 510(k)s, de novos , PMAs and combination products, IDE negotiations, pre-submissions, inspections, warning letters, appeals, and more.

    Lisa Pritchard

    Lisa Pritchard

    Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional-supplement industries. With more than 30 years of experience, she advises clients on regulatory, quality and compliance topics. Pritchard works extensively on worldwide regulatory strategies, marketing submissions and applications spanning the US, the EU and extending to Australia; quality system strategies, SOP development and review, and compliance. Prior to joining DuVal & Associates, she worked at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Pritchard holds a B.S. in electrical and electronics engineering from North Dakota State University.

    Anike Freeman

    Anike Freeman

    Anike Freeman received her B.S. in Bioengineering from the University of Maryland, College Park. Upon graduation, she began working at FDA as a research fellow in the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) and then transitioned to working as a biomedical engineer and reviewer in what is now the Office of Product Evaluation and Quality. She primarily reviewed 510(k)s and pre-submissions for various dental devices such as orthodontic appliances, restorative materials, dental implants, and bone grafting materials. While working, Anike earned her M.Eng. in Bioengineering from the University of Maryland, College Park and transferred to CDRH's Division of Industry and Consumer Education (DICE) as a Consumer Safety Officer. She educated industry on how to comply with U.S. medical device regulations and served as the DICE subject matter expert for medical device adverse event reporting, 510(k)s, and dental devices. She was later promoted to Senior Consumer Safety Officer where she managed division operations for several years. During this time, she received the CDRH Lireka P. Joseph Award for Excellence in Public Health Communication and Education. She now leverages over 10 years of FDA experience in her current work as a consultant at RQM+.

    Dongbo Wang

    Dongbo Wang

    Dongbo Wang, Ph.D. is Senior Director of Regulatory at Galvanize Therapeutics. Galvanize Therapeutics is 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 FDA/CDER/OPEQ regulating dental, general surgical and respiratory devices. Throughout his FDA career he primarily reviewed CDRH premarket submissions – 510(k)s, IDEs, de novos, PMAs, and combination products (device led, drug led, and biologics led). He is very much enjoying the transition to industry and collaborating to create innovative medical devices.

    Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary Wi-Fi
  • Complimentary parking

  • Location

    RAPS Headquarters

    5635 Fishers Ln
    Terrace Level
    Rockville, MD 20852


    Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.


    Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr
    1750 Rockville Pike
    Rockville, Maryland, 20852-1699, USA
    Telephone: (301) 468-1100
    Hotel Website
    Distance to RAPS HQ: .8 miles
    Directions to RAPS HQ

    EVEN Hotel Rockville
    1775 Rockville Pike
    Rockville, MD 20852
    Telephone: (301) 881-3836
    Hotel Website
    Distance to RAPS HQ: .7 miles
    Directions to RAPS HQ

    Be Well Policy

    RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event.

    To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.

    Cancellations and Refunds

    All cancellation requests must be submitted in writing to Cancellation requests received by March 17, 2023, will receive a full refund minus a 20% administrative fee. Cancellation requests received after March 17, 2023, 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 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.

    Photography Policy

    By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.


    Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email  

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