Mandatory Electronic Recall Notices for Medical Devices and Direct Patient Warnings.
This law mandates the use of a standardized electronic format for all medical device recall notifications, significantly speeding up the process. Crucially, it requires manufacturers and healthcare providers to directly inform patients about the risks associated with recalled critical devices (like implants or life support) and the necessary actions they should take. This aims to enhance public safety and ensure citizens receive timely, vital health information.
Key points
Establishes a mandatory, standardized electronic format for all medical device recall notifications, including specific data elements like the Unique Device Identifier (UDI).
Requires direct notification to patients regarding the risks and necessary actions for recalled critical devices (implanted, life-sustaining, or used in pediatrics).
The FDA must maintain a publicly accessible, downloadable electronic database containing all recall information.
Failure to comply with the new electronic submission and patient notification rules constitutes a prohibited act under federal law.
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