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Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
European trade groups and industry experts were cautiously optimistic regarding news that medtech oversight will move from the health directorate to industry, with some saying it will boost innovation and access to new therapies and others worried it could derail progress on regulatory reforms in the EU. Read More
The House of Representatives voted Thursday to repeal the controversial 2.3 percent medical device excise tax, but Democrats and others doubted the effort will get traction in the Senate. Read More
International device regulators laid out their agenda for the next two years, with plans to finalize a regulatory framework for software as a medical device and guidance on international sharing of adverse event data in 2015. Read More
Devicemakers will have 13 new product-specific guides by the end of the year to tell them what quality-related metrics FDA investigators will focus on during site inspections, agency officials said Tuesday. Read More
The FDA has withdrawn a proposed rule reclassifying external pacemaker pulse generators from Class III to Class II and is now issuing a proposed order to make the reclassification. Read More
With 12 recalls in less than 36 months, Johnson & Johnson tops the list of the five medical devicemakers with the most Class I recalls between 2012 and the present, according to FDA data. Read More
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, an FDA Class II special controls guidance recommends. Read More
CDRH is readying its review staff to deal with the additional workload of laboratory-assisted tests, according to a center official who says talks are underway with third-party reviewers to help out. Read More