From the front page of the Wall Street Journal, comes the story about ReGen Biologics’ Menaflex. Clearly, there has been abuse of the 510(k) system. From what I know of this case, there was a ‘stretched’ comparison to the predicate devices, and the use of an expedited process was made even more suspect.

My concern is that (not unlike the mortgage crisis) those companies who have been playing by the rules are going to get punished due to those abusing the rules and an highly questionable management at the FDA.

Read the full article here from today’s Wall Street Journal.