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The U.S. Food and Drug Administration does not mandate the use of specific international standards, allowing manufacturers to explore science-based alternatives. Read More
The U.S. Food and Drug Administration may withdraw a humanitarian device exemption if it subsequently approves a premarket approval application or clears a 510(k) for a humanitarian-use device or a comparable device with the same indication, draft Q&A guidance explains. Read More
The China Food and Drug Administration last month unveiled long-awaited reforms to its medical device regulations, breathing longer life into product licenses, but imposing first-time fees for device registrations. Read More
Covidien is launching its Kangaroo feeding tubes with IRIS technology immediately in the U.S., following the receipt of FDA 510(k) clearance. Read More
The FDA is reopening the public comment period on a 2010 draft guidance on infusion pumps, highlighting its adjusted time estimate for manufacturers to submit case assurance reports.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
Attorneys for Ivy Sports Medicine told a federal judge Tuesday that the FDA did not have authority to reconsider and rescind a classification decision on ReGen Biologics’ Menaflex collagen scaffold device. 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