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The FDA is proposing to establish five categories of Class III devices, delineated by risks, benefits and available controls — a move that could help to streamline classification of high-risk devices and promote consistent expectations about the process. Read More
Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin. Read More