Device changes to address year 2000 bug must be reported but will not be publicly released, FDA says.
This article was originally published in The Gray Sheet
DEVICE CORRECTIONS TO ADDRESS YEAR 2000 DATE CHANGE WILL BE REPORTABLE under FDA's corrections and removals reg, the agency says. To give manufacturers incentive to address the issue before Jan. 1, 2000, however, FDA says device modifications made before this time will not be classified as recalls and not made public by the agency.
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