Is 510(k) Going Away?
Maybe so, according to the FDA announcement of September 23, 2009. Device makers, don't panic. If it happens at all it won't happen for a few years, but the stage may have been set. The text of FDA's announcement can be found
FDA has commissioned the Institute of Medicine to conduct a $1.3 million study of "the premarket notification [510(k)] program used to review and clear certain medical devices marketed in the United States". Its report is scheduled for publication in March 2011. This action seems to have been precipitated most recently by a GAO report in January 2009, which found that the 510(k) program had been used to clear hundreds of complicated medical devices including pacemakers and replacement heart valves. GAO suggested the agency strengthen its approval standards and make them more consistent.
Additional detail on the FDA announcement has been published in the
Wall Street Journal
. Let's be honest, boys and girls. The artifice of substantial equivalence to medical devices marketed prior to 1976 wore thin a long time ago. What the medical device industry--and more importantly the American public--needs is a more rational basis for FDA's clearance decisions for Class I and II devices. There are now very few pre-76 comparisons that can stand up to scientific scrutiny. However, we do have access to a great reservoir of prior device clearances over the last three decades. My solution: have device makers suggest a few of those prior clearances that are most relevant , and have FDA review those comparisons for adequacy with regard to both efficacy and safety. If some clinical trials are needed, so be it; that's no more onerous than what happens today. The right solution does not have to compromise innovation or disadvantage small firms.
So I'm in favor of reforming the 510(k) process, as long as it's done smartly. And, like AdvaMed, I encourage the Institute of Medicine to seek input from industry as its study evolves, and I encourage you to
make your suggestions and concerns known. As it happens,
the Institute is expected to hold two workshops in coming months to gather comments from industry, physicians and patients. You might want to participate or at least monitor the proceedings.