Healthcare Events and Regulatory Fine Print
Healthcare marketers often think their consumer counterparts have all the fun. After all, they’re not constrained by the same legal, medical and regulatory rules when it comes to promoting their products. At Sparks, we firmly believe it’s possible to create exhibits that are entertaining and educational while still playing by the (FDA’s) rules.
The Healthcare Convention & Exhibitors Association (HCEA) offers numerous resources related to healthcare marketing regulations, codes and guidelines in the US. There are a couple of grey areas that medical device marketers should understand clearly when it comes to exhibits, displays and graphics at events. The first is to avoid promoting products for off-label use – that is any use that is not specified in the labeling approved by the FDA. This guidance also applies to verbal interaction with salespeople, for example, not just displays or presentation materials.
Another consideration is providing attendees with an advance look at products in development. In technical terms, these are investigational devices that are the subject of a pending 510(k) from the Food and Drug Administration. The FDA language here is very clear as it relates to promoting a device that has not yet been approved for commercial distribution. While the investigational device may be displayed during an event, “A firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use.”
According to the HCEA, an investigational product that is graphically depicted in a commercial exhibit should:
- Contain only objective statements about the product.
- Contain no claims of safety, effectiveness or reliability.
- Contain no comparative claims to other marketed products.
- Exist solely for the purpose of obtaining investigators.
- Be accompanied by directions for becoming an investigator and a list of investigator responsibilities.
- Prominently display a disclaimer (ex. Caution: Investigational Device – Limited to Investigational Use).
Want to learn more about healthcare marketing regulations, check out HCEA's complete list of guidelines here (http://www.hcea.org)
Posted by Carrie Johnson | Request as a Speaker
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