Tag Archives: Medical devices

17 Feb

Buyer beware in medical devices and cosmetics

Carolyn Merchant Blog 0 0

The FDA mission is to protect the public with regard to food, drugs and cosmetics. In the 1990’s the FDA added the regulation of medical devices. The FDA does not do any clinical studies nor write any labeling—it reviews paperwork. In the past the FDA advocated to limit patients’ right to seek compensation for harm caused by medical devices, thereby advocating for immunity for medical device manufacturers and limiting notice of harm to the FDA. Some argue the FDA can…..

22 Jun

The FDA does not protect us as much as generally believed

Carolyn Merchant Blog 0 0

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…..

19 Feb

The FDA does not protect us from dangerous medical devices

Carolyn Merchant Blog 0 0

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…..

07 Jan

FDA and medical devices

Carolyn Merchant Blog 0 0

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…..

Tag Archives: Medical devices

Buyer beware in medical devices and cosmetics

The FDA does not protect us as much as generally believed

The FDA does not protect us from dangerous medical devices

FDA and medical devices

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Tag Archives: Medical devices

Buyer beware in medical devices and cosmetics

The FDA does not protect us as much as generally believed

The FDA does not protect us from dangerous medical devices

FDA and medical devices

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Recent Comments

Archives

Categories

Meta

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