The Food and Drug Administration (FDA) has called for some adjustments in the implementation of the “FDA Safety and Innovation Act” by shortening the timeline needed in putting in place identification marks on these devices. Original timeline based on the Unique Device Identifier (UDI) program was within seven years from date of enactment of the law.
This was revised by the FDA, which has asked the manufacturers to put in place this requirement to an earlier target. Under this adjustment, manufacturers of medical devices under Class I, II, and III were to have the tracking system in two years.
This law was enacted on July 2012, mandating the creation of a tracking system to monitor the performance by healthcare professionals and manufacturers the performance of these devices. It was also hoped that under this program, the tracking of these medical devices will be easier in the event of a recall or a discontinuation of a particular device.
Read More: FDA Issues Revised, Shortened Timelines for ItsMedical Device Identifier System
This was revised by the FDA, which has asked the manufacturers to put in place this requirement to an earlier target. Under this adjustment, manufacturers of medical devices under Class I, II, and III were to have the tracking system in two years.
This law was enacted on July 2012, mandating the creation of a tracking system to monitor the performance by healthcare professionals and manufacturers the performance of these devices. It was also hoped that under this program, the tracking of these medical devices will be easier in the event of a recall or a discontinuation of a particular device.
Read More: FDA Issues Revised, Shortened Timelines for ItsMedical Device Identifier System