Class III PMA (pre-market approval) has a lot to offer for companies. In addition to getting clear approval for a device, Class III PMA also offers product protections similar in many respects to a patent, making it highly desirable. That being said, it’s also a complex and challenging regulatory pathway to navigate, leading many industry leaders to pursue simpler, but less-rewarding approval options.

Find below a concise overview of the 10 key steps to help you embark on your journey through the new eSTAR submission process. If you need further guidance on eSTAR-related matters, don't hesitate to take advantage of our complimentary one-on-one eSTAR sessions with our experts. Essenvia is here to support the RA community during this challenging transition to eSTAR, and these sessions are offered at no cost to you.

Asking the right questions during pre-submission or Q-submission is essential for manufacturers who want to get effective feedback from the U.S. Food and Drug Administration (FDA). Failure to ask the right questions will set companies up for at least two more rounds of back-and-forth, since they won’t even know what they don’t know yet. Thoroughly reviewing the FDA’s documentation of their Q-submission program is essential, as is anticipating the kinds of issues that a specific product will face in getting through the regulatory process. Failure to prepare in this way is going to lead to a much longer and more costly review process.

The RAPS Convergence 2023, held in Montreal, went incredibly well. The event was perfectly organized, and industry experts had essential knowledge to share. One hot topic that got attention in multiple sessions was eSTAR, which is sensible given the system’s required use in medical device submissions.

Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules […]

The key reasons for submitting a 513(g) request

eSTAR program and how to prepare for a smooth transition

MDCG guidelines on the Periodic Safety Update Report (PSUR)_ How can IVD Manufacturers Benefit

We’re thrilled to announce that we’ve raised a $4M Pre Series A with Wavemaker360 and Benhamou Global Ventures, with participation […]

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to […]

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company […]

Your Guide to European CE Marks for Medical Devices Launching a new medical device is a highly regulated process whether […]

When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is […]

What is GSPR? The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR […]

Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts

Overview Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit

When you are in the early stages of developing a medical device, over half of your activities are regulatory-related.

Being in charge of a product’s regulatory information is complicated enough.

In today’s conversation, we are going to discuss the top 5 reasons why you should not do it alone when submitting your 510(k) application.

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes.