Hospital & Healthcare Management October 3, 2025
The Food and Drug Administration (FDA) has gone on to expand its early alert initiatives so as to cover potentially high-risk removals or even, for that matter, corrections for all the medical devices, the agency confirmed on September 29, 2025.
It is well to be noted that the officials went ahead and announced a pilot of the initiative late in 2024. Ever since then, the agency has gone on to issue certain early alerts shortly after companies have told the customers about certain issues with medical devices.
As per the FDA, the pilot was successful, thereby leading to expanding the program well beyond the initial five therapeutic areas and at the same time also including some high-risk safety events pertaining...
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