Faster Updates for Medical Devices with Safety Plans
This bill allows manufacturers of medical devices to make certain planned updates without needing lengthy new approvals each time. This could mean patients get access to improved devices more quickly, while still ensuring the devices remain safe and effective according to a plan reviewed by regulators.
Key points
Medical device companies can update devices faster if they have a pre-approved plan for changes.
Updates must follow the plan and keep the device safe and working correctly.
Regulators will review the plans to ensure safety standards are met for updated devices.
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