What Are FDA Medical Device Classes? Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing ... Read more December 17, 2024
When & how to File Your Medical Device 510k Submission? Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market ... Read more February 21, 2023
Understanding the regulations for Class III Medical Devices Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes ... Read more February 7, 2023
FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023 Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand ... Read more November 16, 2022