CardioExchange Archive

Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan,  Payal Kohli, and  Sandeep Mangalmurti. View the previous post here and the next one here.

One of the most enjoyable aspects of cardiology is the “toys.” Even as someone who doesn’t implant devices or deploy stents, I appreciate the technologic complexity that they have achieved. However, I hadn’t fully appreciated their associated regulatory complexity. In addition to the issues mentioned in my last posting, yesterday’s symposium entitled “Regulatory Oversight and Protection of Patients’ Interests” offered an eye opening discussion of how differently medical devices are regulated compared with drugs.

The Food and Drug Administration’s (FDA) legal authority to regulate pharmaceuticals comes from the Food, Drug and Cosmetics Act of 1938. Initially, this act did not cover medical devices; FDA regulation of devices did not begin until 1976, prompted by the injuries caused by the Dalkon Shield. In empowering the FDA to regulate devices, Congress set up two different routes for device approval. The first, premarket approval (PMA), parallels the approval process for drugs. Like pharmaceuticals, devices are to undergo rigorous testing before becoming made available to the public. However, in order to grandfather in devices that were already in existence in 1976, a second route known as the “510(k) provision” was developed. Under this route, a device need only show that it is “substantially similarly” to a device already on the market in 1976. The intent of 510(k) was to allow manufacturers to continue to improve these devices without having to begin from regulatory square one.

The 510(k) was meant as an accessory pathway, but due to loosening of the definition of “substantially similar,” the tail is now wagging the dog. Less than 1% of devices are cleared through the rigorous PMA route; instead, new devices with only a tenuous similarity to their predecessors are routinely cleared for general use. For a great case study of this process at work, see “The 510(k) Ancestry of a Metal-on-Metal Hip Implant” Ardaugh B, et al. N Engl J Med 2013;368:97-100. Unfortunately, the 510(k) shortcut has resulted in a significant number of substandard products reaching the market, and then facing recall. In 2011, the Institute of Medicine recommended the FDA move away the 510(k) clearance process, as it does little to ensure device safety or efficacy.

For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.