We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The number of devicemakers that received warning letters from the U.S. Food and Drug Administration following quality system inspections decreased 12 percent in 2013, compared with the previous year — the first decline since 2009. Read More
The U.S. Food and Drug Administration last month unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless there is an immediate threat to public health. 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
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