US Regulatory Essentials, Devices (April 2023)

RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 04 April 2023 (10:00 AM) - Wednesday, 05 April 2023 (3:30 PM) Eastern Time (US & Canada)

Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-day online workshop. Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions.


November 10, 2022 – March 3, 2023: Early Bird $825.00 Member | $970.00 Nonmember 

March 4, 2023 – April 3, 2023: Regular $970.00 Member | $1,150.00 Nonmember


This workshop will benefit individuals who are new to the regulatory profession, entering the medical device industry, or changing companies and/or product lines or industry. The material will also be helpful to anyone studying for the RAC Devices exam.


April 4, 2023


9:45 AM EST

Attendees logged into the webinar and placed in a virtual waiting room

10:00 – 10:20 AM EST          

Welcome and Workshop Overview

  • FDA history
  • FDA organization
  • DICE role

David Chadwick, PhD, RAC, FRAPS, director, regulatory science, Cook Medical

10:20 - 11:45 AM EST

Overview of Medical Devices and IVDS

  • Classification
  • 513(g) and de novo
  • IDE and HDE perspectives
  • PMA perspectives

11:45 – 12:00 PM EST


12:00 - 1:15 PM EST   

Medical Device Breakout

  • 510(k) perspectives
  • EUA (Emergency Use Authorization)
  • Clinical conduct perspectives

Tony Blank, senior director, regulatory affairs, AtriCure, Inc.


IVD Breakout

  • IVD regulation in the US
  • IVD device definitions and classification
  • Steps to IVD commercialization in the US
  • IVD labeling
  • Working with the FDA

Christie Hughes, principal consultant, Qserve Group US Inc.

1:15 - 2:00 PM EST


2:00 – 3:00 PM EST



Etienne Nichols, Greenlight Guru

3:00 PM EST




April 5, 2023


9:45 AM EST

Attendees logged into the webinar and placed in a virtual waiting room

10:00 - 10:05 AM EST

Welcome Back

David Chadwick, PhD, RAC, FRAPS, director, regulatory science, Cook Medical

10:05- 11:15 AM EST

Design Control

Etienne Nichols, Greenlight Guru

11:15- 11:45 AM EST

Postmarket Compliance is No Easy Journey

  • Complaint handling and management
  • Understanding medical device reporting
  • Corrections/Removals (recalls)

Larry Pool, Cook Medical

11:45 AM – 12:00 PM



12:00 - 12:30 PM EST   

Postmarket Compliance is No Easy Journey (continued)

  • Complaint handling and management
  • Understanding medical device reporting
  • Corrections/Removals (recalls)

Larry Pool, Cook Medical

12:30 - 1:15 PM EST


1:15-2:00 PM EST

Navigating an FDA Inspection and Aftermath

The knock on the door

Conduction inspection

Close-out meeting

Post-inspection and enforcement

Andrea , Cook Medical

2:00 PM-3:30 PM EST

Label and labeling

Claims substantiation

Lessons learned from warning letters

Disseminating information about unapproved devices

Intended vs. off-label use

Direct-to-consumer advertising

Social media

Mark DuVal, CEO & President, DuVal & Associates, PA

3:30 PM EST

Wrap-up and Thank You























    David Chadwick

    David Chadwick, PhD, RAC has over 25 years of experience in the medical device industry in such areas as basic research and development, clinical research, and for the past 20 years, regulatory affairs/quality assurance. The scope of his experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, ENT devices, drug delivery, electrosurgery, cardiovascular stents and catheters, with many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. My primary focus resides in medical devices and combination products, but my experience also expands into drug regulation and submission. He currently serves as the director of regulatory science for Cook Medical, providing high-level regulatory and clinical advice on pre- and post-market safety, quality, performance, testing, compliance, and marketing issues pertaining to medical devices globally.

    Christie Hughes

    Christie Hughes has over 25 years of experience in the in vitro diagnostic medical device (IVD) industry. With a degree in clinical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges.

    Mark DuVal

    Mark DuVal, J.D. is president and CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His firm provides strategic regulatory advice; handles product pre-submissions as well as filing, negotiating and appealing 510(k)s, de novos, PMAs and the like; works on compliance and enforcement matters; develops compliance programs; designs and implements sophisticated marketing programs; counsels on reimbursement matters; conducts sales training and interfaces extensively on behalf of companies with the FDA with relation to clinical trial negotiations, enforcement negotiations; policy arguments, appeals of all kinds (LB Flag, 21 CFR 10.75, 517A, etc.) and so on. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, the Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs and Services Program at St. Cloud State University. He is a frequent contributing speaker/panelist to MMDA, Minnesota Medical Alley, RAPS national and the RAPS Minnesota Chapter and is on the programming committee of the Medtech Investing Conference in Minneapolis.

    Etienne Nichols

    Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in a paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

    Tony Blank

    Tony Blank is currently Senior Directory of Regulatory Affairs at AtriCure, Inc. focused on overseeing the regulatory review of medical device promotional material. He has a broad history of leadership in regulatory affairs across the medical device industry - both as a consultant and in leadership roles at small and large medical device manufacturers. Tony's previous 'corporate job' was at Boston Scientific Corporation where he led the cardiovascular regulatory teams. He was likewise an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups – including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He remains involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.

    Andrea Gadsby, Director of Quality Assurance
    Cook Incorporated


    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    All cancellation requests must be submitted in writing to  RAPS is unable to accept cancellations by phone.

    To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee.

    Proof of Attendance

    A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.


    For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop

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

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