US Regulation of Advertising, Promotion and Labeling for Medical Devices

6.0
RAC Credits
Virtual Events
Thursday, 17 June 2021 (12:00 PM) - Friday, 18 June 2021 (4:00 PM) Eastern Time (US & Canada)

Hear from industry leaders, regulatory experts and legal professionals as they share their expertise on medical device advertising, promotion and labeling in the US. Through presentations, discussions and case studies, this virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.

Pricing Amounts & Deadlines

23 Feb – 30 Apr 2021: Early $399 Member | $499 Nonmember

1 May – 23 June 2021: Regular $499 Member | $599 Nonmember

Objective

  • Summarize regulations, enforcement actions, guidelines and trends affecting the advertising and promotion of medical devices
  • Identify key regulatory issues surrounding complex and rapidly shifting hot topics in advertising and promotion, with specific attention on FDA's regulation of social media promotion
  • Examine the current state of off-label promotion
  • Evaluate and use real-world data (RWD) and real-world evidence (RWE) in promotion
  • Discover regulatory applications through case studies
  • Explore the Federal Trade Commission oversight of advertising and promotion
  • Learn more broadly about healthcare regulation of device company interactions with providers, including fraud and abuse and the False Claims Act
  • Discuss proactive Good Promotional Practices designed to ensure compliance including the use of medical advisory committees

Who Should Attend?

  • Early to mid-level regulatory professionals involved in advertising and promotion of medical devices for the US market
  • Regulatory consultants
  • Compliance specialists
  • Food, drug, and medical device attorneys
  • Marketing representatives
  • Medical communications professionals
  • Medical affairs
  • Medical writing
  • Medical Science Liaisons (MSLs)
  • Clinical research professionals

Agenda

Day 1

  • CDRH Overview of Labeling and Advertising
  • Intended Use & Off-Label Promotion
  • Device Claims Substantiation & Comparative Claims

Day 2

  • Navigating Federal Trade Commission (FTC) requirements for medical devices
  • Medical Device Promotional Issues Outside of FDA & FTC
  • Good Promotional Practices

Speakers

Scott Danzis

Scott Danzis, JD, Partner and Chair of Medical Device Practice, Covington & Burling, LLP.

Scott D. Danzis is a Partner in the law firm of Covington & Burling, LLP where he chairs the firm's Medical Device Practice Group. Scott's practice focuses on medical device regulatory matters, including premarket review strategies and postmarket requirements, including advertising and promotion, postmarket reporting, recalls, and enforcement actions, among other things. From 2006 to 2008, Scott served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Master's Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University. Following law school, Scott clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. In addition to his practice, Scott is an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on drug and device law.

Lynn Deutsch

Lynn Deutsch, President & Founder, Regulatory Promo LLC

Lynn Deutsch is a respected regulatory leader in the medical device industry, specializing in advertising & promotion expertise with more than 20 years of experience. In 2017, Lynn founded Regulatory Promo, LLC, a consulting business, sharing her passion for helping others achieve compliance with product launches, public relations, internal communications, social media, audit observations and training – not only from an FDA perspective but in geographies worldwide.

Lynn is an effective communicator with the regulatory knowledge to help achieve the desired core messaging while keeping it cutting edge and compliant. Prior to founding Regulatory Promo, Lynn held regulatory management positions with Varian Medical Systems, Guidant, Medtronic, along with her last industry role at Abbott Vascular, where she was the worldwide director of advertising & promotion for 10 years. Lynn holds a Bachelor of Science degree in business management from Menlo College, Atherton, CA.

Joanne Hawana

Joanne Hawana, MS, JD, Member, Mintz Levin

Joanne Hawana counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.

In recent years, Joanne has been advising clients in different industries regarding FDA’s approaches to precision medicine and the impact of the agency’s policies on product development and marketing plans. She frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims. Prior to joining Mintz, Joanne was an attorney in the food and drug practice in the DC office of another law firm.

Alan Minsk

Alan Minsk, Partner, Arnall Golden Gregory LLP

Alan is a partner and leader of the Food & Drug practice. He advises pharmaceutical, biologic, medical device, cosmetic and food companies (including dietary supplements and medical foods) on all legal and regulatory matters relating to the U.S. Food and Drug Administration. He counsels clients on a wide variety of FDA-related issues including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. In addition, Alan works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, regulatory opinion letters, co-promotions and licensing agreements. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. Alan conducts in-house training on FDA and fraud and abuse topics.

Alan serves as general counsel of Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act, fraud and abuse compliance, and sample accountability. He has written book chapters, articles and bulletins on a wide variety of issues, including 505(b)(2) NDAs, orphan drugs, product promotion, quality agreements, compliance, and medical device regulation. He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine, and the Food and Law Drug Institute's Food and Drug Journal. Alan is nationally recognized by Chambers USA for “Life Sciences: Regulatory/Compliance” has been selected for inclusion in the international publication of Who’s Who Legal for “Life Sciences: Regulatory” and is recognized by Best Lawyers for “FDA Law”.


Bradley Thompson

Bradley Thompson, JD, RAC, Member, Epstein, Becker & Green, P.C.

Bradley Merrill Thompson is a shareholder in the national law firm of Epstein Becker & Green, P.C. There he counsels software, medical device, and drug companies on a wide range of FDA regulatory issues and leads the firm’s AI practice. For trade associations, he has served as counsel to AdvaMed and the Continua Health Alliance, as General Counsel to the Combination Products Coalition, mHealth Regulatory Coalition, the Clinical Decision Support Coalition, and AI Startups in Health Coalition.

Bradley has also served as a member of a workgroup established under the Food and Drug Administration Safety and Innovation Act to identify key considerations to improve patient safety and promote innovation in health information technology, including mobile medical applications, co-chairing the Regulations Subcommittee. He also served as Co-Chair of the Food & Drug Law Committee in the American Bar Association and of the Medical Device Committee of FDLI.


Deborah Wolf

Deborah Wolf, JD, Regulatory Counsel, Division of Premarket and Labeling Compliance, Center for Devices and Radiological Health, FDA






Cancellation Policy

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200