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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
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
Premarket submissions for flow cytometry devices should include a description of quality controls to ensure the device performs accurately throughout its lifecycle, the FDA says. This should include each analytical parameter reported by the device, including fluorescence intensity measures, when relevant. 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
The FDA’s latest tweak to its list of recognized standards add references on catheters and batteries, but withdraws one on blood glucose testing. Read More
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 FDA on Tuesday reversed itself and said it won’t require devicemakers to submit formal reports when they make safety enhancements to their products. Read More
India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More