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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
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, the U.S. Food and Drug Administration says. Read More
The Japanese government is proposing changes to its standards for biological ingredients used to manufacture medical devices, drugs and regenerative medicines. Read More
With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, leaving industry to guess how best to prepare. Read More
Devicemakers or their authorized representatives must report serious adverse events involving their products to regulatory authorities immediately upon learning of a potential link, the Asian Harmonization Working Party says in updated draft guidance released last month. Read More
The International Medical Device Regulators Forum laid out its agenda for the next two years, with plans to finalize a regulatory framework for software as a medical device and guidance on sharing of adverse event data in 2015. Read More
A scientific panel reviewing the use of mercury-containing dental amalgams and alternative materials says evidence of a serious safety risk in either group is weak and the choice of product should be based on patient characteristics. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More