Overhauling the 42-year-old medical device clearance process may lead to compliance confusion and increased research expenses, according to industry attorneys.
The Food and Drug Administration announced plans to modernize its medical devices review program, also known as the 510(k) pathway program, in a Nov. 26 release.
The existing program allows device makers to compare uncleared devices to an already approved device, also known as a predicate device. The predicate devices, however, are usually older and can’t easily be compared to the new machines.
The agency believes that newer devices should be aligned with newer technology and advocates the use of...