USA - CDRH Announces Communications Pilot to Enhance Medical Device Recall Program

​In November 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks. This pilot effort aims to increase transparency and minimize the time between the FDA’s initial awareness of and public communication of potentially high-risk medical device removals or corrections, providing more timely communication to health care providers and the public.

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