FDA warns J&J on illegal marketing of medical devices
Another day, another Johnson & Johnson news item -- and once again, not a flattering one. The drugmaker, which can't seem to get its act straight lately, last week received a warning letter from the U.S. Food and Drug Administration that it is illegally marketing two products. In a letter to J&J's DePuy Orthopaedics, the FDA says it has learned that the company is marketing the TruMatch without the required marketing clearance or approval and in violation of the Federal Food, Drug, and Cosmetic Act. TruMatch Personalized Solutions System is a high-tech CT scanner that can create detailed 3-D views of a patient's knee for implant surgery. The regulatory authority, which recently began a crackdown on medical devices, asked the company to submit information to gain marketing approval. "The FDA will evaluate the information you submit and decide whether your product may be legally marketed," the letter stated.
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