This article was originally published in The Gray Sheet
Manufacturers that distribute devices that are not Y2K compliant after Jan. 1, 2000 must disclose all Y2K problems in device labeling, Center for Devices and Radiological Health Director David Feigal states in a Dec. 10 letter to manufacturers. The center will allow distribution of devices with non-significant Y2K problems, but failure to include the problems in labeling will be considered "false and misleading in respect to device performance." Also, manufacturers must submit new premarket applications for any Y2K correction that raises issues of safety and efficacy, the letter states
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