Medical device makers turn to Europe over concerns with FDA process


Two-thirds of small medical device makers are turning to Europe first to get approval for their products, researchers at Northwestern University write in a new report.

The report comes as the Food and Drug Administration (FDA) is revamping its approval process for low-risk products amid complaints that the process is too slow and unpredictable. Consumer advocates, meanwhile, say dangerous devices are still slipping though the cracks.

According to the new survey, only 8 percent of survey respondents said the FDA's 510(k) approval process is the most predictable. Meanwhile, fully 98 percent said the predictability of the regulatory process is a "crucial factor" in their decision to invest in developing a new product.

"As FDA considers regulatory revisions," lead researcher John Linehan said in a statement, "what's at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace."