Why did ReGen go through the FDA’s 510(k) process to obtain U.S. clearance for its device?
The FDA itself opened the door for ReGen to seek premarket clearance through the 510(k) process. A medical device may be cleared through the 510(k) process if it has the same intended use as a previously cleared device (a so-called “predicate device”) and is found to be at least as safe and effective as the predicate. Prior to its review of the Menaflex device, the FDA already had cleared hundreds of resorbable surgical meshes for use throughout the body through the 510(k) process. Anatomical location has never been a determining factor in finding a device to be substantially equivalent. The Menaflex device is a surgical mesh—and the Director of the Office of Device Evaluation agreed that the device was eligible to be submitted for consideration as a surgical mesh under the 510(k) process. The Menaflex had the same intended use as its predicates—i.e. to reinforce or repair soft tissue. Further, the data show it to be at least as safe and effective as its predicates and that was the con
