Off-label use and medical devices: Here’s what you need to know


Off-label use

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Promoting off-label use of a medical device – a use not included on a device’s indication with FDA – has become a dangerous practice for medtech insiders, with some facing potential prison time for alleged off-label advertising.

But it is still possible to promote off-label use, if you know the rules, says Michael Drues, a regulatory consultant based in the Boston area. “It comes down to how you define the word ‘advertise,'” says Drues, who is president of Vascular Sciences.

President Donald Trump and his FDA commissioner nominee Scott Gottlieb may reduce regulation even more, though Drues says there is a more important question to ask: “What does the regulation really accomplish in the real world?”

If there’s evidence to support off-label use of medical devices, it is OK to encourage the use for the sake of innovation, Drues said. Listen to Drues describe how medical device companies can navigate the confusing world of off-label use promotion.

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