Medical Devices (includes In Vitro Diagnostics)
Much has already been discussed about medical device advertising and promotion, and about the promotion of unapproved devices and unapproved uses of approved devices in the context of scientific exchange, continuing medical education (CME), and trade shows. However, newer avenues for such promotion – particularly via the Internet – raise unique questions for which the answers are not obvious, because FDA’s existing policies do not explicitly cover all of these options for promoting a new device. Perhaps most notably, crowdsourcing begs inquiries about whether a manufacturer’s solicitations for funding of a device constitute commercialization (e.g.., taking orders or at least priming the market), and whether funding the product before it is received counts as a purchase. Thus, it is critical for regulatory professionals to understand how to properly apply FDA's rules and guidance to this new space, in order to effectively advise their business partners/colleagues as to where prospective marketing endeavors fall on the risk spectrum and assist in designing promotional strategies that appropriately balance business needs with regulatory protection.
This session will discuss FDA’s overarching expectations for medical device advertising and promotion, with focuses on how these expectations (1) continue to apply – with slightly different applications – to non-traditional online marketing venues; and (2) are reasonably implemented in the context of crowdsourcing. Case studies of scenarios (both crowdsourcing and other Internet media) where FDA has chosen to intervene will be used to demonstrate key principles and serve as a launchpoint for further discussion. Based on this framework, “best practices” and future considerations will be elucidated which individuals in regulated spaces should understand and take into consideration moving forward.
While this session will focus on medical devices, the principles covered largely apply to other FDA-regulated products as well.