PMA vs 510K: Understanding the Differences in Premarket Approval for Medical Devices

When it comes to getting a medical device approved for market, there are two main routes manufacturers can take: premarket approval (PMA) or premarket notification (510(k)). Both are regulated by the Food and Drug Administration (FDA), but they have different requirements and different levels of scrutiny. In this article, we will explain the key differences […]

Premarket Approval 101: A Comprehensive Guide to the PMA Process for Medical Devices

The premarket approval (PMA) process is a rigorous and comprehensive evaluation of medical devices by the Food and Drug Administration (FDA) to ensure their safety and effectiveness before they can be marketed to the public. In this article, we will provide an overview of the PMA process, including the types of devices that require PMA, […]

The Importance of Clinical Data in Premarket Approval Submission for Medical Devices

When a medical device manufacturer wants to bring a new product to market, they must go through a rigorous premarket approval (PMA) process with the Food and Drug Administration (FDA). One of the most critical components of this process is the submission of clinical data to demonstrate the safety and effectiveness of the device. In […]