Tag Archives: Medical devices
The FDA does far less to protect us than generally believed, leading to potentially dangerous situations due to improper reliance on the FDA. The FDA is authorized to review food, drugs (and medical devices), and cosmetics. The FDA does no clinical studies, and does not write labeling—the FDA reviews paperwork, listens to presenters, and relies on the honesty of the manufacturers and their expert presenters. Approximately 95% of drugs and devices have been approved for marketing under a grandfather…..
The Food, Drug and Cosmetic Act was amended, in 1976, to add regulation of medical devices. A well-intended law has now caused unintended consequences. The FDA views the medical device industry and politicians as its customers, instead of the public; relies on the honesty of what is presented by industry and their paid consultants; and does what politicians direct the FDA to do. The FDA must approve new medical devices and indications as submitted, or reject the device entirely–a politically…..
We discussed problems at the FDA regarding medical devices in The Origin of Disease: The War Within. This article from the Washington Post contains appalling admissions regarding the approval of medical devices by the FDA. The FDA approves dangerous devices when it is convenient, expedient, or in response to political pressure. The FDA does not follow its own regulations regarding medical device approval for 510k products. The FDA exceeds their authority at will to protect industry from claims of harm…..
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