Class I Recall for Gyrus ACMI Ear Device
Class I Recall for Gyrus ACMI Ear Device
A Class I recall has been issued by Gyrus ACMI, Inc. for Micron Bobbin Vent Tube T, 1.27 mm. The recalled device is intended to be implanted for ventilation or drainage of the middle ear. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable [...]
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FDA Weighing Future of Third-Party Device Review
FDA Weighing Future of Third-Party Device Review
Third-party outsourcing of medical device approval is under review, the Wall Street Journal is reporting. Apparently, medical device makers—the Journal cited Philips Electronics NV, Siemens AG, and General Electric Co., for example—do not necessarily need to start the approval process with the U.S. Food and Drug Administration (FDA) and can have third-party companies handle such [...]
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Categories: Slip and Fall Lawyer Tags: Device, Future, Review, ThirdParty, Weighing