FDA addresses industry concerns about device-approval process

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health spoke with medical device makers and other stakeholders in the industry Tuesday in an effort to confront concerns with the overhaul of the medical device approval process.

“By increasing the predictability, reliability and efficiency of the review process, we can help provide better treatments and diagnostics to patients more quickly and stimulate…development of promising new technologies,” said Jeffery Shuren, CDRH director, during a question-and-answer Webcast.

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