{"id":35269,"date":"2013-03-11T11:08:28","date_gmt":"2013-03-11T15:08:28","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=fellowship-training&p=35269"},"modified":"2013-03-11T11:33:53","modified_gmt":"2013-03-11T15:33:53","slug":"devices-vs-drugs-a-distinction-without-a-difference-blogging-from-acc-13","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/03\/11\/devices-vs-drugs-a-distinction-without-a-difference-blogging-from-acc-13\/","title":{"rendered":"Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13"},"content":{"rendered":"

Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include\u00a0Tariq Ahmad<\/strong><\/a>,\u00a0<\/em>Megan Coylewright<\/strong><\/a>,\u00a0<\/em>Jeremiah Depta<\/a>,\u00a0Kumar Dharmarajan<\/a>,\u00a0<\/strong><\/em><\/strong>\u00a0Payal Kohli<\/a><\/strong><\/em>,\u00a0and \u00a0Sandeep Mangalmurti<\/a><\/strong><\/em>.\u00a0View the previous post\u00a0here<\/a>\u00a0and the next one here<\/a>.<\/em><\/p>\n

<\/em>One of the most enjoyable aspects of cardiology is the “toys.” Even as\u00a0someone who doesn’t implant devices or deploy stents, I appreciate the\u00a0technologic complexity that they have achieved. However, I hadn’t fully\u00a0appreciated their associated regulatory complexity. In addition to the\u00a0issues mentioned in my last posting, yesterday’s symposium entitled\u00a0“Regulatory Oversight and Protection of Patients’ Interests”<\/a> offered an\u00a0eye opening discussion of how differently medical devices are regulated\u00a0compared with drugs.<\/p>\n

The Food and Drug Administration’s (FDA) legal authority to regulate\u00a0pharmaceuticals comes from the Food, Drug and Cosmetics Act of 1938.\u00a0Initially, this act did not cover medical devices; FDA regulation of\u00a0devices did not begin until 1976, prompted by the injuries caused by the\u00a0Dalkon Shield. In empowering the FDA to regulate devices, Congress set\u00a0up two different routes for device approval. The first, premarket\u00a0approval (PMA), parallels the approval process for drugs. Like\u00a0pharmaceuticals, devices are to undergo rigorous testing before becoming\u00a0made available to the public. However, in order to grandfather in\u00a0devices that were already in existence in 1976, a second route known as\u00a0the “510(k) provision” was developed. Under this route, a device need\u00a0only show that it is “substantially similarly” to a device already on\u00a0the market in 1976. The intent of 510(k) was to allow manufacturers to\u00a0continue to improve these devices without having to begin from\u00a0regulatory square one.<\/p>\n

The 510(k) was meant as an accessory pathway, but due to loosening of\u00a0the definition of “substantially similar,” the tail is now wagging the\u00a0dog. Less than 1% of devices are cleared through the rigorous PMA\u00a0route; instead, new devices with only a tenuous similarity to their\u00a0predecessors are routinely cleared for general use. For a great case\u00a0study of this process at work, see “The 510(k) Ancestry of a\u00a0Metal-on-Metal Hip Implant”<\/a> Ardaugh B, et al. N Engl J Med\u00a02013;368:97-100. Unfortunately, the 510(k) shortcut has resulted in a\u00a0significant number of substandard products reaching the market, and then\u00a0facing recall. In 2011, the Institute of Medicine recommended the\u00a0FDA move away the 510(k) clearance process<\/a>, as it does little to ensure\u00a0device safety or efficacy.<\/p>\n

For\u00a0<\/em>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\u00a0Coverage Headquarters<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

How are devices regulated? Due to some quirks, the tail now wags the dog.<\/p>\n","protected":false},"author":457,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[1711,719,196,1099,1330,887],"class_list":["post-35269","post","type-post","status-publish","format-standard","hentry","tag-acc-13","tag-devices","tag-fda","tag-health-policy","tag-industry-regulation","tag-iom"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35269","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/457"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=35269"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35269\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=35269"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=35269"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=35269"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}