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FDA 510(k) Clearance vs. Premarket Approval (PMA)

Close up details of hospital operating room interior. Medical devices and life support monitors

This post explains the difference between FDA approval and clearance for medical devices, and how this impacts the level of testing and scrutiny a device undergoes. Knowing whether a device is approved or cleared can also impact a potential lawsuit. It’s important to understand the regulatory process for medical devices to ensure your safety and legal rights.

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