Medical device labeling: You need to design it, too

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medical device labeling intended use

[Image from FDA]

When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston.

Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives to the heart of a company’s regulatory strategy.

“High-level labeling will directly impact your regulatory strategy and your pathway to market,” Drues said. (See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)

Depending on the high-level labeling, the same product could be a wellness device not regulated as a medical device – or a device requiring a 510(k), de novo or PMA. Companies also need to balance out how the labeling will affect winning reimbursement from public and private healthcare payers – not to mention product liability exposure.

The result is that medical device creators need to design their labels like they design their devices, according to Drues, who is president of Vascular Sciences and has worked with both medical device companies and FDA. “To me, design is design.”

Listen to Drues discuss the importance of label design – as well as his four-step design process.


(See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)

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