U.s. Cracks down on health devices made before 1976
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The head of the Food and Drug Administration is making clear to manufacturers of more than 100 untested medical devices already in use that they must present data from rigorous safety tests or face restrictions on their products. Like breast implants, which were restricted earlier this month, these products were in use before 1976, when a law went into effect governing Federal approval of new medical devices. The law also required Federal review of the older products but set no time table. Now the Commissioner of Food and Drugs, David A. Kessler, is making a priority of such reviews. Among the products now facing scrutiny are implants for the testes, shoulders and knees; electrical brain stimulators; balloons that open arteries, and corneal implants for the eye. Other Reviews Planned A top agency official said today: “We are becoming more rigorous. These untested devices need attention. Drugs may be in your system for a day or a week, but many devices are in for good.” The official said the agency would review not only the devices that were not tested after the 1976 law, but also many that got less than rigorous scrutiny when the agency approved them in the late 1970’s and early 80’s. More : query.nytimes.com |