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A government report shows increasing consolidation in the diabetes test strip market since stricter parameters on Medicare coverage of mail-order testing supplies took effect. Read More
Medical devices labeled as latex-free or lacking latex need updated labeling with the more scientifically accurate statement “not made with natural rubber latex,” according to FDA final guidance. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More
Devicemakers are breathing a collective sigh of relief following the Indian government’s decision to let companies affix labels with India-specific information on their products after they enter the country. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More
A pan-European health technology assessment body has recommended that EU cost-effectiveness evaluators compare new pharmaceuticals against the most relevant standards of care, in a new framework to harmonize different member states’ individual guidelines on making coverage decisions. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More
The FDA is revising an August final guidance on design considerations for home use devices to reflect growing concerns about power outages and the potential for electromagnetic disturbances. Read More
By the end of next year, the FDA expects to release rules on the regulation of sunlamps, postmarket safety reporting requirements for combination products and international clinical trials, among other priorities. Read More
The British government says it will conduct a massive review of how new medical devices and in vitro diagnostics are developed, with the aim of bringing products to market faster and speeding patient access. Read More