Substantial Equivalence for Medical Devices for successful US FDA 510(k) registration
For compliance with medical device regulation in the United States, demonstrating substantial equivalence is a pivotal requirement for obtaining FDA clearance through the 510(k) pathway. Substantial equivalence is a concept that ensures a new medical device is as safe and effective as a legally marketed predicate device. Understanding and effectively navigating substantial equivalence is essential […]
Choosing the Right Type of US FDA 510(k) Premarket Notification for Your Medical Device: Understanding the Options
The 510(k) premarket notification process is a critical pathway for medical device manufacturers seeking FDA clearance to market their products in the United States. However, not all 510(k) submissions are created equal. Understanding the different types of 510(k) submissions is essential for navigating this regulatory landscape effectively. In this blog, we’ll explore the various types […]
