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FDA questions needle device Posted 8-31-98 The Food and Drug Administration (FDA) issued a warning against a Canadian-based technology company earlier this month for selling a needle-disposal device in the United States before demonstrating the product’s safety and effectiveness. The FDA’s warning letter, issued Aug. 6 to LG Technologies Group Inc.’s Quebec-based Biotronix 2000 unit, said the company’s product, called NeedleSafe, was being sold in the United States even though it had not yet cleared the FDA approval process. LG and Biotronix spokesperson Lucy Paquette said confusion arose when Biotronix Laboratories bought the device’s patent from U.S.-based Biotronix Technologies, which she said had placed the product for sale on the American market before testing was completed. NeedleSafe provides a kind of mini-combustion chamber, that, after a patient is injected, "destroys used needles through incineration" and reduces them into "harmless non-toxic ash," Paquette said. The FDA letter said the product would be held at the U.S. border until Biotronix wins final FDA approval. The warning letter also asked the company to submit a plan preventing any future U.S. sales of unapproved products. Paquette said the company is doing everything required to comply with the FDA warning, and that Biotronix is now conducting additional tests "regarding the fumes being produced by the combustion process." NeedleSafe is already approved for sale in Europe, having gone through pre-market and regulatory testing for the European Community marketplace, Paquette said. Although it is not used in European hospitals, the product is marketed to diabetic patients for home use. "The product is not yet ready for sale in the U.S. We have submitted the product for pre-market approval, and even though it is advertised on the Web, we are not yet selling it in America," Paquette said. Related Site |
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