How the 'orthopedic capital of the world' is reacting to FDA clearance overhaul

Spinal Tech

Warsaw, Ind., is known as the 'orthopedic capital of the world,' according to Wane.com, featuring Zimmer Biomet, Medtronic and DePuy Synthes manufacturing locations.

Those companies and many others are reacting the FDA's decision to redesign its decades-old medical device clearance system. The current FDA 510(k) clearance pathway has been in place for 40 years. The system allows manufacturers, like Medtronic, to release new devices based on other decade-old products.

The FDA proposed a new system that will be based on clinical testing to receive approval. The pathway will reflect up-to-date safety and effectiveness features. Currently, around 20 percent of devices are being cleared based on a model that is more than a decade old. FDA officials will work on overhauling the approval processes for these devices first.

FDA officials plan to seek out public feedback on released the manes of devices and manufacturers who develop technologies based on the old model.

Officials stressed that while the clearance process is undergoing an overhaul it does not mean the devices are unsafe. Advanced Medical Technology Association spokesperson Greg Crist told Wane.com, "At the end of the day, we all want the same thing, the world's most effective medical devices to treat human suffering in the safest manner possible for patients and their families."

In Indiana, residents have 190,000 classes of medical devices available to them. DePuy Synthes spokesperson Mindy Tinsley told Wane.com, "While we are unable to speculate the potential changes to the U.S. FDA clearance process, we believe a balanced regulatory system is important, and we are open to the continuous improvement of the medical device regulatory system."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Podcast

Featured Whitepapers