Join Essenvia at RAPS Convergence 2026 — Booth #918
· Charlotte, 15–17 September
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Topic
Classification
What is Section 513(g) and How Does it Work
One of the hardest parts of developing a new device is determining exactly how to proceed with regulatory pathway, especially in the case of devices where initial assessments indicate multiple potential classes or uncertainty around clearly-defined class.
The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)
If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company must first ensure that the device is in compliance with each target region’s medical device classification requirements.
510k vs PMA Submissions for Medical Devices in the United States
When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is obtaining FDA clearance.
What does FDA Cleared vs. FDA Approved mean for Medical Devices?
Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules and regulations and level of evidence necessary to obtain FDA permission to market a new or modified medical technology.