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Medical Device Labeling (In-Vitro Lab "Home Brew" off - Label Guidance and Enforcement)

By:
Casper E. Uldriks,
Ex- FDA expert
Robert Klepinski,
Regulatory Attorney, Fredrikson & Byron PA
Coming soon.. Please contact customer care for new schedule

Course Description:

FDA’s medical device advertising and promotion requirements lack legal clarity and has not issued guidance specific to medical devices. You will learn how to navigate the vague legal requirements and FDA’s interpretations for enforcement purposes. What you say and how you say it makes a difference to FDA.

This conference will provide pointers on the basic and subtle ways to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management involves cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries FDA uses and how easy it is to cross them. With information from this course, you can prepare for changes that will take due to new statutory requirements.

Mr. Casper specialized in the FDA's medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health(CDRH) . He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency's expert in a number of statutory provisions and regulations. He continues to teach the FDA's employees to this day.



Learning Objective:

Key goals of the conference will include learning:

  • Learn how FDA interprets advertising and promotion.
  • Understand ways that a firm violates FDA requirements.
  • Understand how corporate interests involve all departments.
  • See how sales and marketing play a central role.
  • Learn how the federal government holds senior management responsible.


Who will Benefit:

  • Marketing Dept., senior managers
  • Sales Dept., senior managers
  • In-house regulatory counsel
  • In-house regulatory affairs directors
  • Consultants for medical device clients
  • Healthcare facility risk managers



Course Outline:

Day One (8.00AM – 4.00PM) Day Two (8.30AM – 4.00PM)

Day 1 / Morning (Casper E. Uldriks)

  • FDA legal authority
  • Advertising
    • Restricted device
    • Regulations
  • Promotion
    • Labeling (21 U.S.C. 321(m))
    • 510(k)
    • PMA
    • IDE
    • Implied knowledge
  • Policy
    • Based on FDA drug regulations
    • Based on FDA drug guidance
    • Agency policy
    • Negotiating with FDA
  • Direct to consumer advertising
    • Federal Trade Commission authority
    • Fair and balanced information
    • Context and format
    • Script versus message
      • Target population
      • Aspirations
      • Emotional factors

Day 1 / Afternoon (Casper E. Uldriks)

  • False and misleading information
    • Statutory basis (21 U.S.C. 352(a))
    • New use
    • Comparative claims
    • Claims for safety and effectiveness
  • Scope of labeling
    • Statutory definition (21 U.S.C. 321(m))
    • Testimonials
    • Internet sites
    • Mobile phone applications
    • Blogs
    • Sale force solicitation
    • Scientific literature and conferences

Day 2 / Morning (Bob Klepinski, Guest Speaker)

  • Off-label marketing
    • Labeling vs. off-label
    • Marketing departments vs. regulatory affairs
    • Exceptions to off-label usage
  • (Group Hypothetical)
  • Responsibility / strict liability
    • Enforcement
    • Penalties
  • Other federal law violations
    • False claims
    • Kickbacks
    • HHS Inspector General
    • Dept. of Justice

Day 2 / Afternoon (Casper E. Uldriks)

  • Case Study
  • Constitutional free speech – First Amendment
  • New statutory requirements
  • Guidance



Meet Your Instructors

Casper (Cap) Uldriks
An ex- FDA expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency's expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA's investigators on the FDA's legal authority and CDRH's regulatory requirements and procedures. He continues to teach the FDA's employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.

Cap also served in the FDA's Office of Legislative Affairs for 5 years as the FDA's congressional liaison for its medical device program. As a federal “Legislative Fellow” he worked for one year in a congressional subcommittee for the Energy and Commerce Committee where he drafted proposed FDA legislation for the regulation of human tissue. He managed and wrote testimony for the Commissioner for several congressional oversight hearings concerning FDA's device program.

Cap now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law) in Washington, D.C. He counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA's requirements.



Robert Klepinski
Regulatory Attorney, Fredrikson & Byron PA

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas and is recognized as one of the leading FDA compliance attorneys. Robert counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Robert was a regulatory attorney for Medtronic, Inc. specializing in implantable and invasive therapies. While at Medtronic, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at both local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools. He is currently an adjunct professor at St. Thomas University in its Graduate School of Engineering and its mini MBA program.




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