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...
7 Reasons to Hire an US FDA 510(k) Consultant for SaMD
Similar to other medical devices, SaMDs will also have to comply with US FDA regulations to be launched in US. Navigating the US FDA regulations for SaMDs can be a daunting task. Hiring an US FDA 510(k) consultant for SaMD can streamline the application process. What...