CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types

Dennis Tosh
October 22, 2025 at 06:33 PM EST
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With the expansion of the FDA’s early alert program to include all types of medical devices, device manufacturers should be prepared for earlier public notifications from the agency of high-risk product recalls. In November 2024, the FDA’s Center for Devices and Radiological Health (CDRH) launched a pilot early alert program for device recalls in cases where manufacturers rem... Read More

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