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BRIEFLY

Health

September 01, 1993|From Times Staff and Wire Reports

New Rule Requires Tracking of Implantable-Device Patients: The decision, which could cost medical device manufacturers millions of dollars a year, was made by the Food and Drug Administration. The new rule was prompted by controversies surrounding the Bjork-Shiley Heart Valve and the Dow Corning silicone breast implants and would also affect makers of ventilators, breathing monitors and heartbeat regulators designed for use at home, the FDA said. "We need a system that will allow us to communicate quickly and effectively critical information about the safety and efficacy of implants and devices," said FDA Commissioner David A. Kessler. "Tracking will help save lives by making it possible to get in touch quickly with people who have faulty devices."

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