Fidelma Conway

What is an FDA 510(k) Submission

by Fidelma Conway
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices need to go through this regulatory pathway? How do you prepare your submission? What happens after you make your 510k submission? Below is an introduction to FDA 510(k) submissions. What is a 510(k) Submission? A 510(k) submission is a pre-market notification that you must submit...

The UDI Requirements of the New EU MDR – What You Need to Know

by Fidelma Conway
The new EU MDR (Medical Device Regulation) changes several aspects of obtaining and then maintaining regulatory approval for medical devices. One of the major changes is the introduction of an identification system, or UDI, for medical devices approved for use in the EU. While the implementation of the new EU MDR has been delayed because of COVID-19, everyone in the industry is impacted by this change in UDI requirements. This includes those with products that have been on the market for years, to companies and start-ups developing new medical devices that have yet to go through the approval process. Introduction...