RAPS Webcast: Medical Device Claims: Staying Out of Trouble with FDA and FTC (On Demand)
Medical device claims can be a bit of a mystery for regulatory professionals to navigate, as there is little published to identify the boundaries. Further confounding is that both the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have roles in the oversight of companies making inappropriate claims. Nuances in labeling of restricted devices versus over the counter (OTC) also make a difference in label content. In this webcast, we will explore the available regulations, case studies of warning letters related to claims, and how you can avoid the FDA’s adulterated and misbranded "label."
Registration Fees & Deadlines
Learning Objectives
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Understand the roles of the FDA and FTC in claims regulation
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Understand existing regulations for contents medical device labeling
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Learn through real-life examples where inappropriate claims resulted in action by the FDA and FTC
Who Should Attend?
Regulatory professionals and marketing personnel that are responsible for developing or approving claims, labeling, and other collateral.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Michelle Lott
leanRAQA, Principal and Founder
Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling(!), because dealing with regulators can be emotionally draining. Her clients delegate those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She serves as mentor in residence for several medical device incubators and guest lectures on regulatory affairs at the Atlantic Technological Institute of Galway and John Hopkins, among others. She holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
