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Devicemakers seeking authorization to market Class II products in Canada will need to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on CE mark certificates issued by European notified bodies, under a government action plan introduced this month. Read More
The Centers for Medicare & Medicaid Services is willing to pay for Myriad Genetics’ Prolaris prostate cancer test via a local coverage determination proposed by a South Carolina Medicare contractor. Read More
The FDA issued a final rule Wednesday placing nucleic acid-based IVDs for the detection of Mycobacterium tuberculosis complex in Class II with special controls. The rule also covers use of the tests to detect genetic mutations associated with MTB complex antibiotic resistance in respiratory specimens. Read More
The U.S. Food and Drug Administration’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
The Medicines and Healthcare products Regulatory Agency is considering charging devicemakers a fee for submissions required to confirm a product’s regulatory compliance. Read More
Manufacturers and importers of drug-eluting stents for the Indian market are coming under fire for allegedly conniving with distributors to hike prices and, in some cases, bribe doctors to use their products. Read More
With investigators from the U.S. Food and Drug Administration set to begin scrutinizing UDI compliance, Class III devicemakers should ensure that UDI changes in their design history files are adequately documented and that a verification process for barcodes is in place. Read More