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The FDA is revising an August final guidance on design considerations for home use devices to reflect growing concerns about power outages and the potential for electromagnetic disturbances. Read More
By the end of next year, the FDA expects to release rules on the regulation of sunlamps, postmarket safety reporting requirements for combination products and international clinical trials, among other priorities. Read More
The British government says it will conduct a massive review of how new medical devices and in vitro diagnostics are developed, with the aim of bringing products to market faster and speeding patient access. Read More
Devicemakers may need to redesign scores of products and change their sterilization methods if the Environmental Protection agency goes through with plans to classify ethylene oxide as carcinogenic when inhaled by humans. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
The American Clinical Laboratory Association and American Medical Association are promising an all-out fight to stop the FDA from requiring premarket applications for high-risk laboratory-developed tests. Read More
Device and diagnostics makers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More