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The FDA is reopening the public comment period on a 2010 draft guidance on infusion pumps, highlighting its adjusted time estimate for manufacturers to submit case assurance reports. Read More
In a bid to cut down on orphan medical device developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
The China Food and Drug Administration has unveiled long-awaited reforms to its medical device regulations, extending the life of product licenses, but imposing first-time fees for device registrations. Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market. Read More