Faster, clearer notifications for recalled medical devices and patient safety.
This law mandates a standardized electronic system for quickly notifying the public and healthcare providers about recalled medical devices. Crucially, it requires manufacturers to provide detailed risk information to facilities and professionals, who must then directly inform patients treated with high-risk devices. This ensures patients receive timely warnings about potential dangers and necessary actions.
Key points
Mandatory, standardized electronic notifications for device recalls, including specific details on patient risks and recommended actions.
Requirement for direct patient notification (via healthcare facilities) regarding the recall of implanted, life-sustaining, or pediatric-use devices.
Creation of a publicly accessible, electronic database containing all information about recalled medical devices.
Failure to comply with the new recall notification rules constitutes a violation of federal law.
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