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Trade shows present potential promotional pitfalls

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 22, 2008

Clinical or medical personnel should be on hand at trade shows to provide information about unapproved uses of approved devices or investigational devices, according to William Kitchens, JD, a partner at Arnall, Golden, Gregory LLP.

Kitchens, who spoke during the Regulatory Affairs Professional Society’s annual conference in Boston, held September 14-17, says companies should separate information about approved devices and those devices or uses still awaiting FDA approval. They should also be the ones answering any unsolicited questions about those uses.

Manufacturers need to be especially careful about written distribution and oral communication of information at trade shows because exhibits are subject to FDA advertising and promotional regulations. Kitchens says companies can display information about devices or uses pending approval, but must state the device or the use is not FDA-approved.  

FDA restrictions on off-label information are not intended to restrict scientific exchange, Kitchens says, but manufacturers must be careful not to editorialize, exaggerate, or commercialize information about investigational devices or unapproved uses. He recommends clinical or medical personnel, not salespeople, handle all unsolicited requests for off-label information.

Medical device manufacturers should establish procedures to review all promotional material prior to distribution, regardless of the content or type of promotion, Kitchens says. The easiest way to stay out of trouble, Kitchens says, is to stick to the FDA approved label. He also recommends training employees so “everyone is on the same page.”

“You don’t want renegade salespeople out there getting the company into trouble,” Kitchens says.

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