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Manufacturers are required to track certain units from their manufacture through the distribution chain after they receive an order from the Food and Drug Administration (FDA) to implement a tracking system for a sure kind of device. The purpose of device tracking is to make sure that manufacturers of sure units establish monitoring programs that can enable them to promptly find devices in business distribution. Tracking data may be used to facilitate notifications and recalls ordered by FDA in the case of serious dangers to health presented by the units. Manufacturers must undertake a technique of monitoring gadgets whose failure would be fairly likely to have critical, antagonistic health consequences; or which is meant to be implanted within the human physique for more than one 12 months; or are life-sustaining or life-supporting units used outdoors of a device consumer facility. Effective, February 19, 1998, the monitoring requirement was changed to eliminate automatic obligatory tracking for certain devices; as an alternative has discretion to order manufacturers of sure forms of Class II or Class III gadgets to provoke a program to trace their medical units all the way down to the patient degree.
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發表於 2025-9-20 03:57:34