FDA 510(k) Clearance vs. Premarket Approval (PMA)
![Close up details of hospital operating room interior. Medical devices and life support monitors](https://b3116388.smushcdn.com/3116388/wp-content/uploads/2023/04/close-up-details-of-hospital-operating-room-interior-medical-devices-and-life-support-monitors-1024x684.jpg?lossy=2&strip=1&webp=1)
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.