US FDA IVD Classification System: A Comprehensive Guide
In vitro diagnostics (IVDs) have a vital role in improving patient outcome and public health surveillance. IVDs are used to detect diseases, monitor health conditions, guide treatment decisions, detect diseases early on, and support precision medicine. Hence, IVDs...
US FDA Medical Device Classification System: Your Guide
The FDA classifies medical devices into three categories based on associated risk level. Each device class requires a different level of regulatory control. These guidelines are in place to ensure the safety and effectiveness of the device. Hence, manufacturers...
US FDA 510(k) Submission for Non-Active Devices: 7-Step Process
Non-active devices form the backbone of clinical practice. They are often simple in design but require rigorous validation to ensure safety, especially when used invasively or for long-term. For non-active medical devices, the 510(k) submission process is rigorous but...