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The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
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 European Parliament advanced major data privacy legislation in March, but not before amending two provisions that industry had said would cripple clinical research. Read More
The UK’s Medicines and Healthcare products Regulatory Agency issued guidance late last month clarifying when standalone software qualifies as a medical device from a regulatory standpoint. Read More
The National Institute for Health and Care Excellence would consider “burden of illness” as a measurable component when assessing new medical devices for reimbursement, under a plan for value-based assessment of health technologies. Read More