{"product_id":"medical-devices-and-the-publics-institute-of-medicine-9780309212427","title":"Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years","description":"\u003cp\u003eMedical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. \u003cbr\u003e \u003cbr\u003e At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. \u003cem\u003eMedical Devices and the Public's Health\u003c\/em\u003e examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. \u003cem\u003eMedical Devices and the Public's Health\u003c\/em\u003e recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Institute of Medicine,Board on Population Health and Public He,Committee on the Public Health Effective\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0309212421\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780309212427\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e National Academies Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 11\/25\/2011\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 318\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.14lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 8.90h x 6.00w x 0.90d","brand":"Institute of Medicine","offers":[{"title":"Paperback","offer_id":48447641551103,"sku":"9780309212427","price":65.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_49d4a534-e661-41c6-b5ce-bb45a6b1f690.jpg?v=1777234054","url":"https:\/\/www.whiterainbookhouse.com\/products\/medical-devices-and-the-publics-institute-of-medicine-9780309212427","provider":"WR Book House","version":"1.0","type":"link"}