There is often a fine line between “legally” promoting a medical device and what the government considers “off-label” promotion. Even accidentally crossing that line can mean serious penalties — from warning letters and fines to disgorgement and even imprisonment of key executives and compliance officers. What attorneys, executives and risk management specialists need are solid strategies specifically geared to medical device manufacturers to keep manufacturers in compliance and out of the courtroom.

During this 90-minute audioconference, Arent Fox partners Linda Baumann and Jamie Ravitz will examine the current and upcoming off-label promotion environment and cover how government prosecutors consider device companies differently than pharmaceutical corporations and how that impacts their enforcement activities. The speakers will also provide strategies specific to device companies, based on recent case studies, to ensure compliant promotional activity.

Participants will have an opportunity to ask questions during the Q&A session.

For more information on this event, please see the FDAnews Web site.