Ensuring Compliant Medical Device Promotion: Aligning Practices with FDA Expectations
1 Hour Video | Julie K. Tibbets, Alston & Bird LLP
Medical device promotion is an essential component of successful product commercialization, and the FDA has broad authority over the labeling of all devices as well as the advertising of “restricted devices”. While various similarities between the FDA’s regulation of medical device and drug promotion do exist, there are numerous important distinctions and, in recent years, greater enforcement of device promotion than drug promotion. Until FDA releases additional guidance in the labeling and promotion area, manufacturers must ensure their sales and marketing teams and promotional review committees adhere to FDA’s expectations to minimize their risk exposure.
- Current promotion recommendations and regulations and FDA guidance development priorities
- Analysis and takeaways from recent enforcement activities
- Case studies: Industry polling on compliance vs. non-compliance
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Advertising & Promotion
- Sales & Marketing Compliance
- Regulatory Affairs
Julie K. Tibbets
Alston & Bird LLP
Julie Tibbets has built her practice around all aspects of FDA-regulated product development and marketing. Julie advises developers, manufacturers and marketers of FDA-regulated products on how to most effectively interact with the agency and minimize regulatory risks. She provides strategic counsel on product development plans and regulatory submissions and works closely with her clients’ in-house teams to build efficiencies and streamline regulatory processes. Her product reach spans biologics, drugs, medical devices, in vitro diagnostics (IVDs), foods, dietary supplements and cosmetics. Julie’s core experience includes advising clients on product development pathways, investor and corporate communications, product labeling, advertising, employee training and interactions with health care professionals. She also counsels clients on adverse event reporting, recalls, product formulations, software and mobile app regulation, Sunshine Act reporting and inspection observation remediation. Since 2013, Julie has appeared on the Washington, D.C., Super Lawyers list of “Rising Stars” in the FDA area and was selected by her peers for inclusion in The
Best Lawyers in America 2016 for FDA law.
1 Hour Video | Anindita Saha and Martin Ho, Center for Devices and Radiological Health