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Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized FDA guidance on substantial equivalence determinations. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness by the government to crack down on illegal ads. Read More
Medtronic’s pending $45 billion acquisition of Covidien was in the congressional spotlight after a recent call by U.S. Treasury Secretary Jack Lew to pass bills limiting corporate inversion deals. Read More
Legislation to allow the Centers for Medicaid & Medicare Services to make coverage decisions more quickly could be on deck before the end of the year, lawmakers suggested during ongoing hearings on the House Energy & Commerce Committee’s 21th Century Cures initiative. Read More
The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
Over the next four years, the U.S. Food and Drug Administration plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
Health Canada has published its 2014 list recognized medical device standards, adding 15 new standards and 10 new editions of currently recognized standards Read More
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More
Citing problems faced by stakeholders, Malaysia’s Medical Device Authority has issued a series of policy notices aimed at helping industry comply with the 2012 Medical Device Act. Read More