FDA Aware Of Heart Device Problems Months Before Issuing A Warning…
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Breaking Home News
Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.
But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential. While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame or how they first interpreted the information.
NY Times | Barry Meier | September 12, 2005 03:37 PM