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Summary and Comments

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1997-07-14 00:00:00


Food & Drug Administration Issues Warning



The Director of the Center for Devices and Radiological Health has posted a warning to manufacturers of medical devices that there is a y2k problem. For any firm submitting premarket devices to the FDA, they must be 2000-compliant. For currently manufactured devices, "manufacturers should conduct hazard and safety analyses to determine whether device performance could be affected by the year-2000 date change. If these analyses show that device safety or effectiveness could be affected, then appropriate speps should be taken to correct current production and to assist customers who have purchased such devices."

New regulations have been posted (June 1, 1997) that require manufacturers to "investigate and correct problems with medical devices that present a significant risk to public health."

In short, the ball is now in business's end of the court. The lawyers are cheering from the stands.

You should visit the "Litigation" category on this site.


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