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The European Commission is again seeking input on the risks associated with di(2-ethylhexyl) phthalate plasticized PVC in medical devices, saying more data is needed before banning its use. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More
A federal court in Texas has ordered Becton, Dickinson to pay $340.5 million and undertake an extensive advertising campaign to resolve monopoly and false advertising claims made by a competitor. Read More
The UK’s health cost-benefit watchdog said Wednesday that there is insufficient evidence on two promising new skin care technologies to justify their routine use. Read More
Devicemakers may use alternative approaches to dual boot designs in new submissions for molecular diagnostic tools that combine approved and unregulated functions if they demonstrate that the nonregulated functions don’t interfere with the approved ones, FDA final guidance says. 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 plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More