Life Sciences Blog

FDA leaves little wiggle room for device makers in reporting of injuries

Posted on July 9th, by Michael Shapiro-Barr

The FDA has issued draft guidance on the requirement of medical device manufacturers to alert regulators to deaths and serious injuries when their devices malfunction and when health care practitioners misuse the device.  Device manufacturers will have 30 days to alert the FDA of such events.

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Media Quotes

  • Mercedes Meyer, a patent lawyer with the firm Drinker Biddle in Washington, D.C., said the Supreme Court’s failure to provide “bright-line guidance”—a ruling that would settle once-and-for all whether patent settlements are legal or not—means there’s “really no difference now than what was going on.” Mercedes Meyer
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